FDA 510(k) Decisions During December, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K021233 12/09/2002 AAP CANNULATED SCREWS AAP IMPLANTATE AG CHRISTIAN ABEL
K023397 12/16/2002 ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES MARGARET PROCHNIAK
K024084 12/31/2002 ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 ABBOTT LABORATORIES FRANK POKROP
K023807 12/26/2002 MODIFICATION TO ALKP ABBOTT LABORATORIES LINDA MORRIS
K022854 12/30/2002 ACELL UBM HYDRATED WOUND DRESSING ACELL, INC PATSY J TRISLER
K021637 12/19/2002 ACELL UBM LYOPHILIZED WOUND DRESSING ACELL, INC PATSY J TRISER
K012691 12/20/2002 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES ACUTRONIC MEDICAL SYSTEMS AG TERRY TORZALA
K023788 12/13/2002 COLUMBUS (CR) TOTAL KNEE SYSTEM AESCULAP, INC. JOYCE KILROY
K023411 12/19/2002 STEELEX STERNUM SET AESCULAP, INC. GEORG KELLER
K023212 12/13/2002 AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS AG GARMENTS ATHENA SHUDDE
K023264 12/19/2002 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K022693 12/09/2002 INSTANT-VIEW TCA URINE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K023936 12/20/2002 MODIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K024102 12/18/2002 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K023996 12/18/2002 ALOKA SSD-3500 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K023299 12/11/2002 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM ALPHATEC MFG., INC. ELLEN A HICKS
K023104 12/16/2002 AMEDICA DRUG SCREEN AMPHETAMINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023101 12/16/2002 AMEDICA DRUG SCREEN METHAPHETAMINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023109 12/16/2002 AMEDICA DRUG SCREEN PHENCYCLIDINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023229 12/13/2002 S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE AMERICAN MAMMOGRAPHICS, INC. ADRIAN PALMER
K023276 12/09/2002 AMSINO TRACHEOSTOMY CARE TRAY AMSINO INTERNATIONAL, INC. DEAN R GAUF
K023161 12/10/2002 SMARTSTEP SYSTEM ANDANTE MEDICAL DEVICE, LTD. ORLY MAOR
K023173 12/18/2002 ANDREWS INTRODUCER, MODEL ASI01 ANDREWS SURGICAL INNOVATIONS, LTD. EMMET ANDREWS
K023769 12/30/2002 PREPARE ADMINISTRATION SET APPRO HEALTHCARE, INC. JOHN R SEMLER
K023405 12/16/2002 TROJAN MINT TINGLE BRAND LATEX CONDOMS ARMKEL, LLC. STEPHEN C KOLAKOWSKY
K023986 12/17/2002 ARTHREX OPES ELECTRODES AND ACCESSORIES ARTHREX, INC. ANN WATERHOUSE
K023119 12/18/2002 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC. ANN WATERHOUSE
K023777 12/11/2002 ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 ARTHRONET MEDICAL, INC. CAROLINA SCHABER
K020683 12/17/2002 ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 ATI MEDICAL, INC. MICHAEL WIENHOLT
K023108 12/03/2002 STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE ATLANTIC PRODUCTS, INC. MAHBUBUR RAHMAN
K021699 12/16/2002 AUTOLENS CLEANING AND DISINFECTING UNIT AUTOLENS INC. RICHARD E LIPPMAN
K021859 12/02/2002 WRIST IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K023160 12/20/2002 DRX5000 AXIOM USA. INC JIM GIBSON
K022640 12/02/2002 SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM BACCHUS VASCULAR, INC. GREGORY J MATHISON
K023514 12/02/2002 TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH) BACCHUS VASCULAR, INC. GREGORY J MATHISON
K022773 12/13/2002 BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K023341 12/23/2002 CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K023340 12/23/2002 CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSOPN
K023322 12/23/2002 CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K023339 12/23/2002 IMAGETILE BARCO NV FRANK FERGUSON
K013562 12/12/2002 AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K022288 12/17/2002 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER CORP. KENNETH T EDDS
K023841 12/24/2002 AMMONIA ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K022177 12/17/2002 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023334 12/31/2002 BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 BAYLIS MEDICAL CO., INC. AMANDA HARTLEY
K023597 12/11/2002 ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY BECKMAN COULTER, INC. MARA CALER
K023480 12/20/2002 ACCESS TOTAL BHCG BECKMAN COULTER, INC. DENISE THOMPSON
K023369 12/09/2002 ACCESS TOTAL T4 ASSAY BECKMAN COULTER, INC. DENISE THOMPSON
K022133 12/10/2002 BD DIRECTIGEN EZ RSV KIT BECTON DICKINSON & CO. COLLEEN A KISTLER
K024109 12/30/2002 BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. JOHN A SCHALGO
K023219 12/06/2002 BECTON DICKINSON DIABETES SOFTWARE BECTON DICKINSON & CO. JOHN SCHALAGO
K023858 12/20/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023527 12/23/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023634 12/24/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) BECTON, DICKINSON & CO. MICHELLE B BANDY
K010185 12/30/2002 6.0 X 5.7MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K022660 12/19/2002 BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 BIOCHECK, INC. ROBIN J HELLEN
K022995 12/02/2002 COLLATEK HYDROGEL BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K023089 12/16/2002 GELSPHERES EMBOLIC AGENT BIOCURE, INC. JOHN GREENBAUM
K023063 12/13/2002 COMPREHENSIVE HUMERAL FRACTURE SYSTEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K023188 12/11/2002 PRESS-FIT HEAD RESURFACING DEVICE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K022952 12/02/2002 MODULAR HEAD BONE SCREW BIOMET, INC. KACY ARNOLD
K024037 12/30/2002 NARROW ASCENT INTERLOK FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K023810 12/04/2002 MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. JUDY SOKUA
K023803 12/11/2002 MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS BIOTRONIK, INC. Jon Brumbaugh
K023147 12/12/2002 ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 BORTEC BIOMEDICAL, LTD. CARL YOUNGMAN
K023870 12/20/2002 FLEXIMA BILIARY CATHETER BOSTON SCIENTIFIC/MEDI-TECH NICHOLAS CONDAKES
K023489 12/16/2002 QUICKTOX MULTIPLE DRUG DIPCARD BRANAN MEDICAL CORP. CHIA HER
K023961 12/24/2002 SCOUT BOSS BURKE, INC. DUWAYNE E KRAMER JR.
K023374 12/18/2002 GROSHONG NXT DUAL LUMEN PICC CATHETERS C.R. BARD, INC. PEGGY KEIFFER
K023193 12/20/2002 CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP. William McGrail
K024058 12/30/2002 MODIFICATION TO CARDEON AEGIS CATHETER CARDEON CORP. JANE BEGGS
K022584 12/30/2002 CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING CARDIOTECH INTL. ANDREW M REED
K023466 12/13/2002 TULIP ALGINATE IMPRESSION MATERIAL CAVEX HOLLAND B.V. RICHARD WOORTMAN
K023328 12/12/2002 REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES MELISSA MAHALL
K023347 12/06/2002 VITAL STIM CHATTANOOGA GROUP CHERYL BAGWELL
K023370 12/24/2002 CHEETAH I.V.D.S., MODEL 2002P CHEETAH MEDICAL INC. ARAVA HACOHEN
K023732 12/10/2002 CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR CIBA VISION CORPORATION TERRINA WILDER
K023661 12/06/2002 LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K023125 12/18/2002 COALESCENT U-CLIP- AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K023922 12/20/2002 COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 COAPT SYSTEMS, INC. SHELLEY TRIMM
K023581 12/02/2002 COMFORT AGILE SCOOTER, LY-EW303 COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K023655 12/13/2002 ENHANCE HTF MEDIUM WITH HEPES CONCEPTION TECHNOLOGIES GRACE HOLLAND
K023717 12/13/2002 SPERM WASH MEDIUM WITH GENTAMICIN CONCEPTION TECHNOLOGIES JOHN CORCORAN
K023731 12/24/2002 QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 CONSOLIDATED TECHNOLOGY CANDICE BETZ
K023349 12/24/2002 CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) CONTAMAC LTD. MARTIN DALSING
K023353 12/20/2002 SYDNEY IVF HYALURONIDASE COOK UROLOGICAL, INC. DEBBIE SCHMITT
K023379 12/11/2002 COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER COOPER SURGICAL JOSEPH M AZARY
K023383 12/13/2002 COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER COOPER SURGICAL JOSEPH M AZARY
K023382 12/20/2002 COOPERSURGICAL MALLEABLE SYTLET COOPER SURGICAL JOSEPH M AZARY
K023384 12/13/2002 COOPERSURGICAL TRIAL TRANSFER CATHETER COOPER SURGICAL JOSEPH M AZARY
K023907 12/18/2002 CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER CORDIS CORP. DONNA MARSHALL
K023327 12/02/2002 CYNOVAD ZIRKON CYNOVAD NAOUM ARAJ
K023361 12/16/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K023541 12/13/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K022284 12/10/2002 SNORE-AID MAX DENTAL IMAGINEERS, LLC WILLIAM A BELFER
K023115 12/18/2002 ACE VERSANAIL DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN, J.D.
K023786 12/10/2002 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K021039 12/11/2002 BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM DEPUYACROMED KAREN F JURCZAK
K023330 12/11/2002 BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K022713 12/18/2002 DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC. JAMES L BROWN
K023152 12/17/2002 IMMULITE 2000 ALLERGEN-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K023304 12/09/2002 IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K023543 12/02/2002 EVLT KIT AND D15PLUS AND D30PLUS DIODE DIOMED, INC. SAMUEL D WADE
K023233 12/13/2002 EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM EBI, L.P. JON CAPAROTTA
K023757 12/05/2002 CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 ENDOCARE, INC. EBEN GORDON
K023886 12/12/2002 ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D ERBE USA, INC. JOHN TARTAL
K023880 12/11/2002 CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER ETHICON, INC. PETER CECCHINI
K022715 12/19/2002 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE ETHICON, INC. REY LIBROJO
K022933 12/02/2002 EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT EVENFLO COMPANY, INC. MATTHEW G MCCARTY
K023485 12/02/2002 EXPLORER POWERED WHEELCHAIR EVERMED CORP. ROBERT S MCQUATE
K023993 12/27/2002 GALAXY SERIES WHEELCHAIR EVERMED CORP. CALVIN CHANG
K024030 12/12/2002 MILLENNIUM SERIES MANUAL WHEELCHAIRS EVERMED CORP. CALVIN CHANG
K020533 12/02/2002 EXEL VACULET BLOOD COLLECTION SET EXELINT INTL. CO. ARMAND HAMID
K023017 12/13/2002 TUCKER EMBRYO CATHETER FERTILITY TECHNOLOGY RESOURCES, INC. THOMAS J ZINNANTI
K023362 12/09/2002 FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN FISHER DIAGNOSTICS JERALD STEINER
K021548 12/06/2002 FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM FOTONA D.D. MOJCA VALJAVEC
K023241 12/24/2002 TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE M. FRANK LEWIS
K023574 12/04/2002 GIZMO FREEDOM DESIGNS, INC. GINNY S MALOCO
K023554 12/20/2002 DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE GE LUNAR CORP. JAMES P RASKOB
K023932 12/11/2002 GE PHOTON ENERGY RECOVERY (PER) OPTION GE MEDICAL SYSTEMS F.I. HAIFA HEMY NEUMAN
K021726 12/12/2002 GEBAUER'S INSTANT ICE GEBAUER CO. SUZANNE B WOJCIK
K023380 12/03/2002 T-WAVE ALTERMANS (TWA) ALGORITHM OPTION GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K023246 12/23/2002 AMALGA PACS GLOBAL CARE SOLUTIONS, S.A. CARL ALLETTO
K023320 12/10/2002 AGILTRAC .035 PERIPHERAL DILATATION CATHETER GUIDANT CORP. MICHELLE GROSSMAN
K023007 12/05/2002 DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. RICHARD D BLISS
K021775 12/23/2002 LTFS230 HEALTHTRONICS, INC. PETER WEIMAN
K023259 12/26/2002 INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 HELIX MEDICAL, INC. CYNTHIA M ANDERSON
K023491 12/13/2002 AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM HELP TECHNOLOGIES ROBERT J BARD
K023784 12/24/2002 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K022690 12/23/2002 PAROS CRP HORIBA LTD. IAN GILES
K022905 12/13/2002 LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER HORIZON MEDICAL PRODUCTS, INC. SCOTT MOELLER
K022993 12/02/2002 HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS HOVEROUND CORP. TONY DIGIOVANNI
K023087 12/16/2002 GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K024060 12/20/2002 MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K023267 12/11/2002 T2 SUPRACONDYLAR NAIL SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K022928 12/11/2002 HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS HUDSON DIAGNOSTIC IMAGING LLC MARTIN E WENDELKEN
K023938 12/13/2002 MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 HUTCHINSON TECHNOLOGY, INC. THOMAS A DOLD
K022945 12/18/2002 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA HYCOR BIOMEDICAL, INC. RANDY WILSON
K022944 12/18/2002 AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA HYCOR BIOMEDICAL, INC. RANDY WILSON
K021509 12/24/2002 HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 HYGIA HEALTH SERVICES, INC. GEOFF M FATZINGER
K023883 12/20/2002 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO I-FLOW CORP. SHANE NOEHRE
K023827 12/13/2002 PARAGON INFUSION SYSTEM WITH BOLUS I-FLOW CORP. SHANE NOEHRE
K022009 12/30/2002 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K023242 12/04/2002 I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE IMPLANT SCIENCES CORP. JEFFREY GIBBS
K022377 12/10/2002 THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 IMPLEX CORP. ROBERT A POGGIE
K023067 12/03/2002 IMTEC SENDAX MDI ORTHO6 AND ORTHO8 IMTEC CORP. BRAD VANCE
K023500 12/13/2002 DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306 INNOVATECH, INC TONY C.S. CHANG
K023269 12/23/2002 HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K022979 12/18/2002 LAPARETTE, MODEL LAP J L S H N INSTRUMENTS MEDICAUX G.B., INC. MARTIN PAQUETTE
K022911 12/02/2002 MODEL AMI1200 C-ARM INTEGRITY PRACTICE MANAGEMENT, INC. KEVIN J MEURET
K022048 12/04/2002 INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM INTERPORE CROSS INTL. LYNN M RODARTI
K021915 12/19/2002 TRANSITIONAL IMPLANTS INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
K023222 12/26/2002 ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 INVITROCARE, INC. ROBERT E LOVINS
K022086 12/23/2002 AIM-V (R) MEDIUM, MODEL 087-0112 INVITROGEN CORPORATION KEITH D GITTERMAN
K023035 12/02/2002 SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K022147 12/20/2002 DENTA PORT J. MORITA USA, INC. KEITH A BARRITT
K024036 12/20/2002 PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 JOHARI DIGITAL HEALTHCARE, LTD. NISHA JOHARI
K022762 12/16/2002 JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 JOMED, INC. TERRY SCHULTZ
K023132 12/17/2002 JOSTRA MECC SYSTEM JOSTRA AG KATHLEEN JOHNSON
K023853 12/13/2002 K-ASSAY LP(A) CONTROLS KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K023187 12/02/2002 KSEA SPINOSCOPE KARL STORZ ENDOSCOPY JAMES A LEE
K014277 12/11/2002 KSEA DEPLOYABLE CARDIOVASCULAR CLAMP KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K023305 12/26/2002 KEGELMASTER 2000 KEGELMASTER 2000 LTD. YOLANDA SMITH
K021501 12/02/2002 V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT KINETIC CONCEPTS, INC. WILLIAM H QUIRK
K021500 12/20/2002 VACUUM ASSISTED CLOSURE KINETIC CONCEPTS, INC. WILLIAM H QUIRK
K023770 12/12/2002 K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) KINETIKOS MEDICAL, INC. JOHN SPAMPINATO
K024025 12/18/2002 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR KOSSAN LATEX INDUSTRIES (M) SDN. BHD. JAMES F LOGAN
K023143 12/19/2002 ECHO SOUNDER, ES-102EX KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K023292 12/13/2002 APEX HRI DIGITAL RADIOGRAPHY SYSTEM KRUGMAN TECHNOLOGIES, INC MICHAEL A KRUGMAN
K021643 12/13/2002 HA ORBITAL IMPLANT LABORATOIRE VILLANOVA ISABELLE DRUBAIX
K023832 12/13/2002 SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. JOHN E HUGHES
K022888 12/11/2002 ACUBEAM, SUPER NOVA, DIO LIGHT FORCE THERAPY, INC. LEWIS WARD
K023317 12/12/2002 METHADONE ENZYME IMMUNOASSAY Lin-Zhi International, Inc. CHIU CHIN CHANG
K023316 12/16/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. CHIU CHIN CHANG
K022723 12/26/2002 MASTEL 1 FOLDER IMPLANTATION SYSTEM MASTEL PRECISION, INC. MAUREEN WEINER
K023098 12/09/2002 ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT MCKINLEY INFUSER JOHN CHAPPELL
K023789 12/06/2002 O.B. TAMPONS MCNEIL-PPC, INC. DIANA L.B. UHL
K023293 12/23/2002 MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 MED-TEC,INC. DONALD F RIIBE
K023084 12/16/2002 MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL MEDICAL ADVANCES, INC. ANTHONY DIETZLER
K023669 12/19/2002 MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K023867 12/17/2002 MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K023928 12/11/2002 MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K023081 12/16/2002 PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K022732 12/13/2002 INFANT/CHILD REDUCED ENERGY ELECTRODES MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K014296 12/10/2002 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K023797 12/13/2002 LAURAIN DEWALD ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
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