FDA 510(k) Applications Received During December, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K004009 12/26/2000 3M ATTEST 290 AUTO-READER 3M COMPANY STEPHAN NORSTED
K003723 12/04/2000 3M LITTMANN 3M COMPANY LINDA JOHNSEN
K003949 12/21/2000 TACKER, MODEL R65-933 A & A MEDICAL, INC. JIHAD MANSOUR
K003762 12/06/2000 ALI 3D TOOL MODULE FOR MEDICAL IMAGES A.L.I. TECHNOLOGIES, INC. ROBERT MACNEIL
K003746 12/04/2000 3D-DOCTOR ABLE SOFTWARE CORP. YECHENG WU
K003708 12/01/2000 ADVANTAGE THC/COCAINE TEST ADVANTAGE DIAGNOSTICS CORP. JANIS FREESTONE
K003759 12/06/2000 AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR AESCULAP, INC. DAVID W SCHLERF
K003740 12/04/2000 MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION AESCULAP, INC. DAVID W SCHLERF
K003965 12/22/2000 MRI SAFE INSTRUMENTS AESCULAP, INC. LISA M MILLINGTON
K003978 12/22/2000 AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 AFX, INC. NANCY NORRIS
K003763 12/06/2000 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES GRETEL LUMLEY
K003940 12/21/2000 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES GRETEL LUMLEY
K003819 12/11/2000 HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A AGILENT TECHNOLOGIES, INC. TERESA SKARR
K003768 12/06/2000 MONARCH II IOL DELIVERY SYSTEM ALCON RESEARCH, LTD. SHERRI J LAKOTA
K003881 12/15/2000 INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003879 12/15/2000 INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) ALFA SCIENTIFIC DESIGNS, INC. NAIISHU WANG
K003845 12/12/2000 MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003847 12/12/2000 MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K003739 12/04/2000 ALOKA SSD-4000 ALOKA CO., LTD. CHRISTOPER BOHL
K003999 12/26/2000 AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 AMERICAN TELECARE, INC. CHARLES RICHARD ABBRUSCATO
K003901 12/18/2000 ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K003769 12/06/2000 ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K003771 12/06/2000 ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K003895 12/18/2000 X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 ANSELL PERRY JAMES R CHATTERTON
K003787 12/08/2000 NEWTOM QR-DVT 9000 APERIO SERVICES, LLC GREGORY W BOWMAN
K003923 12/20/2000 APEX MODULAR ZIRCONIA FEMORAL HEAD APEX SURGICAL, LLC. EDWARD J CHEAL
K003871 12/15/2000 LAPAROSCOPIC HAND PORT APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K004015 12/27/2000 BEAM BLOCK TRAYS ARPLAY MEDICAL S.A. RICHARD BORGI
K003778 12/07/2000 BREAST-BOARD (MULTIPLE) ARPLAY MEDICAL S.A. RICHARD BORGI
K003779 12/07/2000 IMMOBILIZATION SYSTEM FOR ENT ARPLAY MEDICAL S.A. RICHARD BORGI
K004023 12/27/2000 INTRA OPERATIVE RADIATION THERAPY ARPLAY MEDICAL S.A. RICHARD BORGI
K003777 12/07/2000 CARIS SITE MARKER ARTEMIS MEDICAL, INC. ROBIN BUSH
K003988 12/26/2000 UROSCOPE, ARTES MEDICAL, USA ARTES MEDICAL USA, INC. WILLIAM KIRKPATRICK
K003816 12/11/2000 ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM ARTHREX, INC. VERNON C BROWN
K010303 12/05/2000 ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE ARTSCAN MEDICAL INNOVATIONS ROBERT ANTHONY
K003971 12/22/2000 AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K003986 12/26/2000 ULTRASOUND SCANNER TYPE 2102 B-K MEDICAL A/S VILLY BRAENDER
K003749 12/04/2000 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN BANTA HEALTHCARE YOLNDA SMITH
K003975 12/22/2000 BAUMER CEMENTED HIP PROSTHESIS BAUMER S.A. BRENO C FARAGO
K003976 12/22/2000 BAUMER MULLER HIP PROSTHESIS BAUMER S.A. BRENO C FARAGO
K003747 12/04/2000 C1-INHIBITOR MICROTITER ASSAY DEVICE BAXTER HEALTHCARE CORP. ARLENE VIDOR
K003730 12/04/2000 CHEMO-AIDE DISPENSING PIN BAXTER HEALTHCARE CORP. JUDY KANNENBERG
K003796 12/08/2000 ADVIA 120 HEMATOLOGY BAYER CORP. FREDRICK CLERIE
K003861 12/13/2000 BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) BENZ RESEARCH AND DEVELOPMENT CORP. MARTIN DALSING
K003896 12/18/2000 LYMPHA VISION-EXPERT BEXLEY TRADING, INC. MICHAEL ZMUDA
K003827 12/11/2000 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION BIO-PLEXUS, INC. PAUL A TENTHOREY
K003851 12/12/2000 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 BIOCHECK, INC. ROBIN J HELLEN
K003954 12/21/2000 STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT BIOCOMPOSITES LTD. J. STEPHEN BRATT
K003948 12/21/2000 EPI-DERM SILICONE GEL SHEETING BIODERMIS CORP. JEFF S SCHLEUING
K003867 12/12/2000 EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) BIOFILM, INC. ROBERT L DE ARMOND
K003908 12/19/2000 SEROJET BIOJECT, INC. NANCY J GERTLAR
K003795 12/08/2000 BIOLUCENT MAMMOGRAPHY CUSHION BIOLUCENT, INC. STEVE GEX
K003856 12/13/2000 EZ-HCG URINE(PREGNANCY TEST) BIOMERICA, INC. JAY SINGH
K003756 12/06/2000 BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES BIONX IMPLANTS, INC. DAVID W ANDERSON
K003970 12/22/2000 CONTOUR LABRAL NAIL, MODEL 533520A BIONX IMPLANTS, INC. TUIJA ANNALA
K003757 12/06/2000 THERMOFX MESH BIONX IMPLANTS, LTD. TUIJA ANNALA
K003752 12/05/2000 BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K003770 12/06/2000 BIRD TBIRD LEGACY VENTILATOR BIRD PRODUCTS CORP. TOM GUTIERREZ
K003735 12/04/2000 BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K003839 12/12/2000 CENTRAL VENOUS CATHETER BOSTON SCIENTIFIC CORP. THERESA A MCGOVERN
K003782 12/07/2000 CONSTELLATION CATHETER, MODEL 8031 BOSTON SCIENTIFIC CORP. ANDREA BOUMIS
K003929 12/20/2000 NIROYAL BILIARY PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC CORP. JODI L GREENIZEN
K004022 12/27/2000 M3 (MIRCO-MULTILEAF COLLIMATOR BRAINLAB AG STEFAN VILSMEIER
K004034 12/28/2000 MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 BRANAN MEDICAL CORP. RAPHAEL WONG
K003732 12/04/2000 BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES BRAUN GMBH FRED SCHLADOR
K003917 12/19/2000 MODIFICATION TO FLUOROTEX II SURGICAL MESH BRIDGER BIOMED, INC. BRUCE G RUEFER
K003906 12/19/2000 MODIFICATION TO FLUROTEX SURGICAL MESH BRIDGER BIOMED, INC. BRUCE G RUEFER
K003828 12/11/2000 VASO PRESS DVT FOOT GARMENT #VP 520 BRITT CORP., INC. J J BRITTON
K003956 12/21/2000 BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 C.R. BARD, INC. BETH A ZIS
K003793 12/08/2000 BARD LUMINEXX BILIARY STENT C.R. BARD, INC. CAROL VIERLING
K003876 12/15/2000 US SENSOR #CG-930P; TOCO SENSOR CG-940P CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K003707 12/01/2000 CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A CARDIONET DONALD CANAL
K003885 12/15/2000 VISULAS YAG II CARL ZEISS, INC. SCOTT A MARGOLIN
K003791 12/08/2000 CAVEX TEMPORARY CEMENT CAVEX HOLLAND B.V. RICHARD WOORTMAN
K003927 12/20/2000 Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 CHEEN HOUNG ENT. CO. LTD. JAY WANG
K003826 12/11/2000 FOCUS DAILIES PROGRESSIVES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K003833 12/11/2000 SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR CLEARLAB PTE LTD. JOHN M SZABOCSIK
K003958 12/21/2000 COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE COALESCENT SURGICAL MICHAEL A DANIEL
K004046 12/29/2000 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K003880 12/15/2000 CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) CONCENTRIC MEDICAL, INC. SAM LAZZARA
K003716 12/01/2000 CONFORMANCE CHEMISTRY CONTROL C3 CONSOLIDATED TECHNOLOGY RUSTY SEWELL
K003715 12/01/2000 COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II COOLTOUCH CORP. DONALD V JOHNSON
K003781 12/07/2000 COOLTOUCH VARIA-II ND:YAG LASER SYSTEM COOLTOUCH CORP. DONALD V JOHNSON
K003920 12/19/2000 CORDIS M3 PTA DILATATION CATHETER CORDIS CORP. CHARLES (CHUCK) J RYAN
K003964 12/22/2000 TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B CORDIS CORP. KAREN WILK
K003925 12/20/2000 PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. Amarilys Machado
K004039 12/29/2000 CYNOSURE PHOTOGENICA NEO-V CYNOSURE, INC. GEORGE CHO
K003963 12/22/2000 DIMENSION PSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. GEORGE M PLUMMER
K003870 12/15/2000 THROMBOREL S DADE BEHRING, INC. REBECCA S AYASH
K003998 12/26/2000 FLEXVIEW CLINICAL MONITORING SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K003790 12/08/2000 DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 DAVOL, INC. LUCINDA L FOX
K004031 12/28/2000 NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES DENTAL POWER, INC. JOHN SCHOEFFEL
K003921 12/20/2000 DYRACT CEM LCI COMPOMER DENTSPLY INTL. P. JEFFREY LEHN
K003822 12/11/2000 ISOLA CLOSED DUAL ROD CONNECTOR DEPUY ACROMED FRANK MAAS
K003797 12/08/2000 ACE AIM TTC FUSION NAIL DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003800 12/08/2000 AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K003875 12/15/2000 TI-REPLICA HIP STEM DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K004002 12/26/2000 IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K003767 12/06/2000 ASSERACHROM HPIA TEST KIT DIAGNOSTICA STAGO, INC. ANDREW LOC B LE
K004001 12/26/2000 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR DIDECO BARBARA WATSON
K003977 12/22/2000 DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET DISETRONIC MEDICAL SYSTEMS AG DAVID E CHADWICK
K003960 12/21/2000 DJ ORTHOPEDICS TIBIAL ANCHOR DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K003993 12/26/2000 DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) DORNIER SURGICAL PRODUCTS, INC. WALTER PAYERL
K004016 12/27/2000 SHEER THIN AROMAS BLUE LATEX CONDOM EAGLE TWE, INC. KEITH F HEINTZ
K004036 12/28/2000 SHEER THIN AROMAS GREEN LATEX CONDOM EAGLE TWE, INC. KEITH F HEINTZ
K004051 12/29/2000 SHEER THIN AROMAS YELLOW LATEX CONDOM EAGLE TWE, INC. KEITH F HEINTZ
K003898 12/18/2000 EBI VUECATH SPINAL ENDOSCOPIC SYSTEM EBI, L.P. JON CAPAROTTA
K003764 12/06/2000 MODIFICATION TO EBI SPINELINK SYSTEM EBI, L.P. FREDERIC TESTA
K003955 12/21/2000 LASEREX INTEGRE, MODEL LP2532 Ellex Medical Pty. Ltd. KEITH DEGENHARDT
K003897 12/18/2000 ENDIUS BIPOLAR SHEATH ENDIUS, INC. SUSAN FINNERAN
K003811 12/11/2000 CRYOCARE SURGICAL SYSTEM ENDOCARE, INC. VINCENT CUTARELLI
K003864 12/13/2000 INJEX 50 SYSTEM EQUIDYNE SYSTEMS, INC. JIM BARLEY
K003741 12/04/2000 JET SYRINGE MODEL-100500 EQUIDYNE SYSTEMS, INC. JIM BARLEY
K003953 12/21/2000 INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 ETHICON ENDO-SURGERY, INC. JACKIE HUGHES
K003952 12/21/2000 INDIGO LASEROPTIC TREATMENT SYSTEM ETHICON ENDO-SURGERY, INC. JACQUELYN A HUGHES
K003776 12/07/2000 MICROTARGETING DRIVE SYSTEM FHC, INC. FREDERICK HAER
K003855 12/13/2000 HYALOMATRIX CO FIDIA ADVANCED BIOPOLYMERS SRL PAOLO RAMPAZZO
K003894 12/18/2000 ORACLE ORAL MASK FISHER & PAYKEL HEALTHCARE, LTD. DARRYN ALEXANDER
K003973 12/22/2000 RESPIRATORY HUMIDIFIER, MODEL HC150 FISHER & PAYKEL HEALTHCARE, LTD. CHRIS MANDER
K003957 12/21/2000 DIACLEAR ULTRAFILTER GAMBRO RENAL PRODUCTS SUZANNE DENNIS
K003817 12/11/2000 PATTERN RESIN GC AMERICA, INC. TERRY L JORITZ
K003947 12/21/2000 FUNCTIONAL BRAIN MAPPING OPTION FOR MRI GE MEDICAL SYSTEMS LARRY A KROGER
K003946 12/21/2000 SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE MEDICAL SYSTEMS LARRY A KROGER
K003849 12/12/2000 GE ADVANCE NXI PET SYSTEM GE MEDICAL SYSTEMS, INC. D DUERSTELER
K003931 12/20/2000 VIVID 7 WITH SONOPAC, MODEL FB0008XX GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K003837 12/12/2000 FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM GE OEC MEDICAL SYSTEMS TED PARROT
K004014 12/22/2000 MD 30 COMPACT GENERAL PROJECT CORNELIA DAMSKY
K003831 12/11/2000 ARTHROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003807 12/08/2000 CYSTOSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003830 12/11/2000 ENT ENDOSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003803 12/08/2000 GENERAL SURGICAL LAPAROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003805 12/08/2000 GYNECOLOGICAL LAPAROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003802 12/08/2000 HYSTEROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003806 12/08/2000 URETEROSCOPES GLOBAL ENDOSCOPY, INC. NICK MIRCEA
K003812 12/11/2000 VACUETTE SPEEDY QUICK-RELEASE HOLDER GREINER VACUETTE NORTH AMERICA, INC. Judi Smith
K003889 12/18/2000 ANCURE SHEATH MODEL # 40315, 40320, 40325 GUIDANT CARDIAC AND VASCULAR SURGERY JACQUELINE J JACKSON
K003872 12/15/2000 GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K003922 12/20/2000 NITRILE EXAMINATION GLOVES (POWERED) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K003985 12/26/2000 POWDERFREE NITRILE PATIENT EXMINATION GLOVE GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD SUSAN D GOLDSTEIN-FALK
K003915 12/19/2000 ACCUFUSER; ACCUFUSER PLUS HELPTECHNOLOGIES ROBERT J BARD
K003744 12/04/2000 ENRAF-NONIUS ENDOMED 182 SYSTEM HENLEY HEALTHCARE, INC. REBECCA STOUT
K003930 12/20/2000 FLEXTIME MAGNUM 360 HERAEUS KULZER, INC. CHERYL ZIMMERMAN
K004008 12/26/2000 STRESS GUARD, MODEL HERDEV1 HERBO MEDEX INTERNATIONAL, INC. RICHARD KEEN
K004044 12/29/2000 HOMMED SENTRY III PATIENT MONITOR SYSTEM HOMMED LLC. TOMMIE J MORGAN
K003848 12/12/2000 HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003840 12/12/2000 CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES I.C. MEDICAL, INC. CRAIG HARSHMAN
K003736 12/04/2000 MRI LINE MARKER I.Z.I. CORP. HELEN ZINREICH
K003754 12/05/2000 IMMUNETICS C6 LYME ELISA KIT IMMUNETICS, INC. ANDREW E LEVIN
K004013 12/27/2000 IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY IMPLEX CORP. JOHN SCHALAGO
K004012 12/27/2000 IMPRA CARBOFLO EPTFE VASCULAR GRAFTS IMPRA, INC. LORRI CHAVEZ
K004011 12/27/2000 IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS IMPRA, INC. LORI CHAVEZ
K004047 12/29/2000 HOME-AWAY SYSTEM IN-X CORP. CHARLIE HENRY
K003854 12/13/2000 INTRAVASCULAR ADMINISTRATION SET INFUSION DEVICES, INC. PAUL E DRYDEN
K003905 12/19/2000 ACTI-ICP MONITORING SYSTEM INNERSPACE, INC. DONALD E BOBO
K003959 12/21/2000 QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA INOVA DIAGNOSTICS, INC. BRY C MYERS
K003714 12/01/2000 OSSTELL RESONANCE FREQUENCY ANALYZER INTEGRATION DIAGNOSTICS LTD CONSTANCE BUNDY
K004003 12/25/2000 PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 INTERPORE CROSS INTL. LYNN M RODARTI
K003892 12/18/2000 TOTAL BILIRUBIN REAGENT INTERSECT SYSTEMS, INC. JOAN CATHEY
K003997 12/26/2000 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS INTRATHERAPEUTICS, INC. AMY PETERSON
K003939 12/21/2000 VENTURE HOME FILL II, MODEL IOH 200 INVACARE CORP. EDWARD A KROLL
K003751 12/05/2000 HYALURONIDASE REAGENT, MODEL CAT#2212 INVITROCARE, INC. ROBERT E LOVINS
K003882 12/15/2000 NUCAMMA BI90 IS2 RESEARCH, INC. VICTOR WOODBURN
K003835 12/12/2000 JAS MAGNESIUM REAGENT JAS Diagnostics, Inc. David Johnston
K003912 12/19/2000 PHOSPHORUS REAGENT JAS Diagnostics, Inc. David Johnston
K003829 12/11/2000 TOTAL BILIRUBIN JAS Diagnostics, Inc. David Johnston
K003938 12/20/2000 TRAK BACK II JOMED, INC. CHRISTINA KICHULA
K004037 12/28/2000 X-RAY SYSTEM XR-MX KARL STORZ ENDOSCOPY JENNIFER S PORTUGAL
K003994 12/26/2000 KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K003883 12/15/2000 MOLINA ORBITAL MALAR DISTRACTOR KLS-MARTIN L.P. MIKE TEAGUE
K003765 12/06/2000 LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) LASERSCOPE PAUL H HARDMAN
K003760 12/06/2000 TAI-CHI ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
DEN000008 12/19/2000 DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. JONATHAN S KAHAN, ESQ.
K003720 12/04/2000 ANGEL OF WATER COLON HYDROTHERAPY SYSTEM LIFESTREAM PURFICATION SYSTEMS, LLC. RICHARD A HAMER
K003943 12/21/2000 MICROGAS 7650 TRANSCUTANEOUS MONITOR LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K003984 12/26/2000 SUPER REVO SUTURE ANCHOR LINVATEC CORP. LAURA D SENEFF
K004006 12/26/2000 SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER LUMENIS, INC. KAREN BAKER
K003862 12/13/2000 MADA WHEELCHAIRS MADA MEDICAL PRODUCTS, INC. JEFFREY W ADAM
K004028 12/27/2000 ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING MAERSK MEDICAL, LTD. LARA N SIMMONS
K003982 12/22/2000 TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR MAGNETIC RESONANCE EQUIPMENT CORP. G. RONALD MORRIS
K003913 12/19/2000 HINT AUDIOMETER, OR HINT MAICO-DIAGNOSTICS DANIEL EGGAN
K003877 12/15/2000 MAR COR SERVICES SEMPER PURE RO MACHINE MAR COR SERVICES, INC. ANDREW G STITZINGER
K004050 12/29/2000 PANASONIC TELE-HOMECARE SYSTEM MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. DAVID L WEST
K003924 12/20/2000 MAVIDON MEDICAL ELECTRODE JELLY MAVIDON MEDICAL PRODUCTS TIM CARROLL
K003783 12/07/2000 MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER MEDICAL DEPOT, INC. ART WARD
K003761 12/06/2000 NAT - NUCLEIC ACID TRANSPORT MEDICAL PACKAGING CORP. RICHARD CURTIS
K003699 12/01/2000 MEDIVISION IGS SYSTEM MEDIVISION (U.S.A.), INC. SANDRA WILLIAMSON
K003755 12/05/2000 MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K003937 12/20/2000 CPR EZY MASK AND PAD MEDTEQ INNOVATIONS PTY LTD EDUARDO MARCH
K003979 12/22/2000 MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K003914 12/19/2000 MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES MEDTRONIC PS MEDICAL JANET MCAULEY
K003718 12/04/2000 TITANIUM CEMENT RESTRICTOR (TCR) MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K003928 12/20/2000 TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K003780 12/07/2000 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K003724 12/04/2000 CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B MEDTRONIC VASCULAR MARIE HOLM
K003873 12/15/2000 MENTOR SELF-CATH CLOSED SYSTEM MENTOR CORP. DONNA A CRAWFORD
K003784 12/07/2000 MENTOR SELF-CATH PLUS MENTOR CORP. DONNA A CRAWFORD
K004005 12/26/2000 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) MENTOR CORP. DONNA A CRAWFORD
K003815 12/11/2000 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
K003966 12/22/2000 WUNDCATH CONDUCTION CATHETER MICOR, INC. JEREMIAH COSTELLO
K003794 12/08/2000 ELISA TEST, SEROLOGY MICRO DETECT, INC. MEDHI ALEM
K003712 12/01/2000 MODIFICATION TO MALE TO MALE LUER ADAPTER MOLDED PRODUCTS INC. ELISE JOHNSTON
K004017 12/27/2000 H-SCRIBE MORTARA INSTRUMENT, INC. HARLAN L VAN MATRE
K003899 12/18/2000 IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM MRI DEVICES CORP. WILLIAM DINEHART
K003804 12/08/2000 SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 NIKO MEDICAL PRODUCTS RICHARD A HAMER
K004007 12/26/2000 DR180+OXY NORTHEAST MONITORING, INC. RODNEY L CAMBRE
K003902 12/19/2000 MULTITRACK ANGIOGRAPHIC CATHETER NUMED, INC. NICHELLE R LAFLESH
K003972 12/22/2000 NUMED GHOST II PTA CATHETERS NUMED, INC. NICHELL LAFLESH
K003820 12/11/2000 DISPOSABLE CB-PE MICROKERATOME BLADES OASIS MEDICAL, INC. YVONNE FERNANDEZ
K004000 12/26/2000 OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K003996 12/26/2000 OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERMETTE
K003721 12/04/2000 MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K003824 12/11/2000 OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI OMNISONICS MEDICAL TECHNOLOGIES DOUG CHARLAND
K004049 12/29/2000 POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) OPTECH, INC. MARTIN DALSING
K003704 12/01/2000 OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) OPTOVENT AB CLAES RYMOND
K004021 12/27/2000 F1 DIODE LASER SYSTEM OPUS MEDICAL, INC. CONNIE WHITE-HOY
K003893 12/18/2000 VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X ORATEC INTERVENTIONS, INC. LINDA GUTHRIE
K003733 12/04/2000 SCS CLOSED SCREW ORTHOTEC, L.L.C. PATRICK BERTRANOU
K003823 12/11/2000 SCS DT-02 TRANSVERSE CONNECTOR ORTHOTEC, L.L.C. PATRICK BERTRANOU
K003918 12/19/2000 OSCOR PERMANENT PACING LEAD RZ MODEL SERIES Oscor Inc. MILA DOSKOCIL
K003886 12/18/2000 PALOMAR SPALIGHT PULSED LIGHT SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. Marcy Moore
K003951 12/21/2000 PECTOFIX STERNAL REPAIR WIRE PECTOFIX, INC. ERIC BANNON
K003775 12/06/2000 PORTABLE BREAST COMPRESSION DEVICE PEM TECHNOLOGIES T. WHIT ATHEY
K003992 12/26/2000 PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM PERCUSURGE, INC. MATTHEW J MOON
K003737 12/04/2000 POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K003858 12/13/2000 MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 PHAMATECH CARL A MONGIOVI
K003853 12/12/2000 INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DUANE PRASCHAN
K003705 12/01/2000 XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 PHOTO MEDEX, INC. AL MEMMOLO
K003725 12/04/2000 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS PIE MEDICAL COLLEEN J HITTLE
K003932 12/20/2000 BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY POLYMER TECHNOLOGY NANCY ABRAHAM
K003933 12/20/2000 BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY POLYMER TECHNOLOGY NANCY ABRAHAM
K003842 12/12/2000 PRESCOTT'S SURGICAL SPEAR PRESCOTT'S, INC. PAUL REDNER
K003909 12/19/2000 PROACT 1 PROACT CO. JEAN ROZINT
K003843 12/12/2000 ENVIVE MINIFORMS PROCTER & GAMBLE CO. KATHLEEN C BLIEZNER
K003904 12/19/2000 POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES PURNABINA SDN BHD LIEW YOON FONG
K003874 12/15/2000 CBC-4K HEMATOLOGY CONTROL R & D SYSTEMS, INC. KENNETH EDDS
K003991 12/26/2000 CD-CAL PLUS CALIBRATOR R & D SYSTEMS, INC. KENNETH T EDDS
K003809 12/08/2000 RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS RAPID DIAGNOSTICS, INC. CHARLES C.F. YU
K004040 12/29/2000 REDTECH GIPC 2000 RED-TECH, INC. GARY MOCNIK
K003745 12/04/2000 LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET RLN SYSTEMS, INC. J. LEE REA
K004010 12/26/2000 ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS ROCHE DIAGNOSTICS CORP. LUANN OCHS
K003846 12/12/2000 ACCU-CHEK INFORM METER ROCHE DIAGNOSTICS CORP. MIKE FLIS
K003967 12/22/2000 CA 125 II CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003865 12/13/2000 COBAS INTEGRA AMPHETAMINES ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K003969 12/22/2000 ELECSYS CA 125 II CALSET ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003772 12/06/2000 ELECSYS DHEA-S CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003941 12/21/2000 ELECSYS HCG STAT CLASET II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003734 12/04/2000 SERUM PROTEIN SUBSTITUTE SAGE BIOPHARMA GRACE HOLLAND
K003916 12/19/2000 DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM SCANDIA MANUFACTURING LTD. RONALD E BERGLUND
K004038 12/28/2000 TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 SCANTIBODIES LABORATORY, INC. RICHARD LENART
K003711 12/01/2000 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P SEIN ELECTRONICS CO., LTD. WON-KY KIM
K003934 12/20/2000 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) SELTOM PACIFIC SDN. BHD. S. SEAGARAN
K003701 12/01/2000 SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) SENTECH MEDICAL SYSTEMS, INC. LYDIA BIGGIE
K003945 12/21/2000 OPDIMA SIEMENS MEDICAL SOLUTIONS USA, INC. PRAVEEN NADKARNI
K003710 12/01/2000 DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 SMITH & NEPHEW, INC. JANICE HASELTON
K003990 12/26/2000 SOFRADIM PARIETEX SURGICAL MESHES SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE
K003789 12/08/2000 SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT SPECIALTY ULTRAVISION, INC. DEBBIE MCINTIRE
K003729 12/04/2000 ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), ST. JUDE MEDICAL ANGELA BYLAND
K003857 12/13/2000 STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES STERILMED, INC. PATRICK FLEISCHHACKER
K003983 12/26/2000 STIMUPLEX HNS-11 STOCKERT GMBH DOMINIKA SCHULER
K003792 12/08/2000 STRYKER HEATED INSUFFLATOR TUBE SET STRYKER CORP. MICHAEL BAYCURA
K004027 12/27/2000 STRYKER REMOTE SURGICAL PLANNING SYSTEM STRYKER INSTRUMENTS NICOLE PETTY
K003758 12/06/2000 ALLOFIT ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003801 12/08/2000 ANATOMICAL PRESS-FIT HUMERAL STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003832 12/11/2000 SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K003748 12/04/2000 TIANXIE SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. HENRY WOO
K003808 12/08/2000 TAKE 1 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K003836 12/12/2000 SYNTHES SYNEX SPACER SYSTEM SYNTHES JONATHAN GILBERT
K003786 12/08/2000 SMF RESORBABLE MESHES AND SHEETS SYNTHES (USA) THOMAS M MAGUIRE
K003700 12/01/2000 SYNTHES HAMSTRING LOOP SYNTHES (USA) THOMAS M MAGUIRE
K003743 12/04/2000 SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K003788 12/08/2000 SYNTHES RESORABLE MESHES AND SHEETS SYNTHES (USA) THOMAS M MAGUIRE
K003703 12/01/2000 TAUT-INSUFFLATION NEEDLE TAUT, INC. RONALD KENSETH
K003987 12/26/2000 URS-1K (KETONE TESST) TECO DIAGNOSTICS DINDO CARRILLO
K003717 12/04/2000 INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. HARALD JUNG
K003911 12/19/2000 TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) TERRAY CORP. STEVE WANG
K004019 12/27/2000 ANA EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K004026 12/27/2000 BRAIDED GUIDING INTRODUCER THOMAS MEDICAL PRODUCTS, INC. PETER J RAPP
K003731 12/04/2000 SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE THOMAS MEDICAL PRODUCTS, INC. PETER J RAPP
K004025 12/27/2000 SPLITTABLE SHEATH INTRODUCER KIT THOMAS MEDICAL PRODUCTS, INC. KIMBERLY A FISCHER
K004048 12/29/2000 SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) TILLOTSON HEALTHCARE CORP. F.W. PERRELLA
K003818 12/11/2000 TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS TITAN IMPLANTS LYNETTE L HOWARD
K003936 12/20/2000 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING TOMTEC IMAGING SYSTEMS, GMBH FLORIAN EISENBERGER
K004018 12/27/2000 SKINGARD POLYCOAT GLOVE TOP QUALITY MFG., INC. ART WARD
K003728 12/04/2000 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM TORNIER DAVID W SCHLERF
K003834 12/12/2000 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K003868 12/14/2000 SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K004045 12/29/2000 SUSCEPTIBILITY TEST PANEL TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K003995 12/26/2000 SPECULITE/ORALLITE TRYLON CORP. MARTIN LONKY
K003890 12/18/2000 VHF ULTRASONIC ARC-SCAN SYSTEM ULTRALINK, LLC. GEORGE D WISEMAN
K003709 12/01/2000 SURGICAL DYNAMICS MESH CAGE SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER E SCHUCK
K003753 12/05/2000 GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE URESIL CORP. CHARLES P GILL
K003719 12/04/2000 VASCULAR ARCHITECTS PERISCOPE DEVICE VASCULAR ARCHITECTS, INC. JEAN M CAILLOUETTE
K003773 12/06/2000 CLEAN SCRAPE WEBB RESEARCH II, INC. STEVEN KRUPNICK
K004043 12/29/2000 METAL TRANSCEND ARTICULATION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K004032 12/28/2000 PERFECTA AND EXTEND WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K003910 12/19/2000 NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS ZIMMER, INC. STEPHEN MCKELVEY


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