FDA 510(k) Decisions During October, 1997  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K972823 10/10/1997 MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER A & A MEDICAL, INC. ADIB KHOURY
K973579 10/28/1997 AM SERIES HEARING AID A & M HEARING, LTD. MARIA E BONILLA
K972607 10/10/1997 PLATALLOY AALBA DENT, INC. VINCENT M BENETTI
K973265 10/16/1997 VERABOND 2V AALBA DENT, INC. VINCENT M BENETTI
K973811 10/21/1997 POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) ABSOLUTE QUALITY LEADERSHIP, INC. DONNA DI GANGI
K972718 10/01/1997 M-2 ANTERIOR PLATE SYSTEM ACROMED CORP. GREG CANNEDY
K971980 10/23/1997 MCD-AC ADAC LABORATORIES DENNIS W HENKELMAN
K972763 10/20/1997 HEMAPROMPT AERSCHER DIAGNOSTICS ROBERT SCHREIBER
K972789 10/17/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972780 10/20/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972786 10/17/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972746 10/21/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972787 10/17/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P ALEXANDER MFG. CO. KEN HEIMENDINGER
K972779 10/20/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P ALEXANDER MFG. CO. KEN HEIMENDINGER
K972801 10/21/1997 ALLIANCE RUBBER, EC-GRIP ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K971015 10/22/1997 AHCS HEMOPERFUSION SYSTEM AMERICAN HEALTH CARE SYSTEMS, INC. EARL G SCHMIT
K972561 10/06/1997 NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY AMERICAN LASER MEDICAL DANIEL HOEFER
K972765 10/21/1997 NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER AMERICAN LASER MEDICAL DANIEL HOEFER
K971576 10/16/1997 REJOYN PENILE SUPPORT SYSTEM AMERICAN MEDTECH DONALD R STONE
K973142 10/20/1997 DBEST REAGENT STRIP FOR URINALYSIS AMERITEK, INC. K.C. YEE
K972862 10/31/1997 AMPLAID 171S AMPLIFON S.P.A. DANIEL KAMM
K973107 10/02/1997 AMSINO I.V. ADMINISTRATION SET AMSINO INTL., INC. RICHARD Y LI
K972918 10/27/1997 RAPID FIRE HAIR IMPLANTER CAROUSEL APEX MEDICAL PRODUCTS, LLC. NORMAN R ESTRIN
K973352 10/27/1997 BRAND NAME *1-STEP PREGNANCY ARMKEL, LLC. THERESA SINES
K973310 10/27/1997 TBD* ONE-STEP OVULATION PREDICTOR TEST ARMKEL, LLC. THERESA SINES
K970864 10/17/1997 ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS ARROW INTL., INC. THOMAS D NICKEL
K973418 10/09/1997 UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) ASSEMBLY REQUIRED DIST., INC. ROBERT J MURPHY
K972964 10/10/1997 ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K973260 10/21/1997 HYDRASORB STERILE DRESSING AVITAR, INC. PAUL H PATRONE
K971935 10/01/1997 B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) B & D CORP. LADISLAU BIRO
K971259 10/27/1997 COMBIPORT FLUID LAVAGE DEVICE B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K972703 10/01/1997 REDYROB-CLOSED WOUND DRAINAGE SYSTEM B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K971233 10/17/1997 SOFT TIP EPIDURAL CATHETER KIT B. BRAUN MEDICAL, INC. MARK S ALBERGE
K973846 10/29/1997 AIR CONDUCTION HEARING AID BARON TRADING, INC. PHILLIP RECHISTER
K961008 10/10/1997 AUTOMIX 3+3/AS COMPOUNDER SYSTEM BAXTER HEALTHCARE CORP. MARCIA MARCONI
K972579 10/01/1997 HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE BAXTER HEALTHCARE CORP. DAVID C ROSS
K973654 10/24/1997 VIAL-MATE RECONSTITUTION DEVICE (2B8071) BAXTER HEALTHCARE CORP. TAMIMA ITANI
K964098 10/31/1997 CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP. GABRIEL J MURACA, JR.
K971989 10/22/1997 TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP. GABRIEL J MURACA
K973743 10/31/1997 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC. MICHELE Z BURTNESS
K973966 10/31/1997 ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC. SHELLIE GUST
K970742 10/22/1997 TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS ANNA LONGWELL, ESQ.
K972929 10/20/1997 N ANTISERUM TO HUMAN ALBUMIN BEHRING DIAGNOSTICS, INC. RUTH FORSTADT
K972840 10/17/1997 N ANTISERUM TO HUMAN TRANSFERRIN BEHRING DIAGNOSTICS, INC. RUTH FORSTADT
K973832 10/27/1997 OPUS HLH CONTROLS BEHRING DIAGNOSTICS, INC. RUTH FORSTADT
K972807 10/15/1997 (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBI BENZ RESEARCH AND DEVELOPMENT CORP. PATRICK H BENZ
K973948 10/28/1997 DUALINE 100 BTE BERNAFON-MAICO, INC. RAY ENROTH
K973043 10/27/1997 MODEL C-1 HEARING AID BETTER HEARING, INC. LOUIS T GNECCO
K971501 10/14/1997 SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K971273 10/08/1997 INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K962783 10/23/1997 EDEMA SYSTEM BIOANALOGICS, INC. CAROL L PATTERSON
K972860 10/31/1997 CURVTEK TSR SYSTEM BIOLECTRON, INC. RICHARD S DUGOT
K972895 10/03/1997 VIDAS ROTAVIRUS (RTV) ASSAY BIOMERIEUX VITEK, INC. TERRY MCGOVERN
K972691 10/15/1997 ABC TOTAL ELBOW PROTHESIS BIOMET, INC. KARL SCHWARTZ
K965141 10/31/1997 TRUQUANT BR RIA BIOMIRA USA, INC. JILLIAN CASTRUCCI
K973126 10/06/1997 TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I BIOSITE INCORPORATED JOHN F BRUNI
K973112 10/10/1997 ELECSYS DIGOXIN BOEHRINGER MANNHEIM CORP. YVETTE R LLOYD
K972876 10/09/1997 GLUCOTREND BASIC SYSTEM BOEHRINGER MANNHEIM CORP. MIKE FLIS
K973358 10/06/1997 MYOGLOBIN CONTROL SET BOEHRINGER MANNHEIM CORP. YVETTE LLOYD
K973629 10/07/1997 PRECINORM RF, PRECIPATH RF BOEHRINGER MANNHEIM CORP. YVETTE R LLOYD
K973015 10/09/1997 MULTITAK SS SUTURE SYSTEM BONUTTI RESEARCH LYNNETTE WHITAKER
K972986 10/08/1997 ACCURUN 140 RUBELLA IGG POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K971320 10/09/1997 CRE BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K971367 10/27/1997 BRAINSCAN CONFORMAL RT MODULE BRAINLAB, AG STEFAN VILSMEIER
K973125 10/08/1997 MAMMOLOADER BY C.M.A. SRL C.M.A. CARL ALLETTO
K973500 10/16/1997 BARD ENDOSCOPIC OVERTUBE (#000307) C.R. BARD, INC. MARION GORDON
K971137 10/16/1997 BARD RAPIDFIRE MULTIPLE BAND LIGATOR C.R. BARD, INC. BETH A ROCHETTE
K971265 10/23/1997 VIKING DIAGNOSTIC ELECTRODE CATHETER C.R. BARD, INC. ANNE KULIS
K970741 10/16/1997 POWERHEART AECD CARDIAC SCIENCE, INC. RAYMOND COHEN
K972762 10/14/1997 CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES CARDIOMETRICS, INC. CLAIRE ANDREWS
K970638 10/30/1997 CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT CARDIOTHORACIC SYSTEMS, INC. MICHAEL J BILLIG
K973431 10/28/1997 LASETTE CELL ROBOTICS, INC. CONNIE WHITE
K971013 10/28/1997 CHASE TEMPERATURE PROBE CHASE MEDICAL, INC. BERT DAVIS
K972495 10/10/1997 ACCUMETER THEOPHYLLINE TEST CHEMTRAK, INC. SUBBARAO GUNUPUDI
K972968 10/08/1997 ROTOGRAPH PLUS CHICAGO X-RAY SYSTEMS, INC. AL SOSA
K972808 10/24/1997 HANSATOME MICROKERATOME CHIRON VISION CORP. JUDY F GORDON
K970595 10/24/1997 CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP CIRCON VIDEO TODD J POLK
K970143 10/29/1997 C4 CLINICON CORP. ALAN BUNTING
K971712 10/08/1997 COEUR 130 ML ANGIOGRAPHIC SYRINGE COEUR LABORATORIES, INC. CHRISTINE L PANZL
K972530 10/01/1997 CONVATEC ODOR CONTROL WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIENNE MCNALLY
K972977 10/10/1997 INSULATOR WIRE GUIDE COOK UROLOGICAL, INC. TAMMY BACON
K972825 10/07/1997 OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB CORDIS CORP. MIRJAM BARBOZA
K972978 10/21/1997 VISTA BRITE TIP GUIDING CATHETERS CORDIS CORP. KATHERINE TREVISOL
K970264 10/28/1997 CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM CORDIS WEBSTER, INC. MARY ADAMS
K973634 10/29/1997 COULTER AC.T DIFF ANALYZER COULTER CORP. THOMAS J ENGLISH
K972257 10/20/1997 N-ASSAY TIA ANTITHROMBIN III TEST KIT CRESTAT DIAGNOSTICS, INC. MARY REES
K971985 10/20/1997 N-ASSAY TIA PLASMINOGEN TEST KIT CRESTAT DIAGNOSTICS, INC. MARY REES
K972662 10/01/1997 CRYOGEN CRYOSURGICAL SYSTEM CRYOGEN, INC. CHERYL L SHEA
K970570 10/03/1997 NIVP3 (WINDOWS VERSION OF NIVP D. E. HOKANSON, INC. D. E HOKANSON
K973650 10/20/1997 TROPONIN (TROP) METHOD DADE CHEMISTRY SYSTEMS, INC. REBECCA S AYASH
K973668 10/20/1997 CARDIAC TROPONIN-I (TROP) CALIBRATOR DADE INTL., INC. REBECCA S AYASH
K972799 10/10/1997 DRIED GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. SHAROLYN J LENTSCH
K972910 10/14/1997 PORS ON LITE DEGUSSA CORP. HOLGER MEINICKE
K973422 10/28/1997 LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) DEJARNETTE RESEARCH SYSTEMS ERIC J FINEGAN
K973492 10/21/1997 DENTALVIEW PERIOVIEW SYSTEM DENTALVIEW, INC. WENDELL EBLING
K972629 10/09/1997 DEPUY AE TK2 HIP SCREW SYSTEM DEPUY, INC. KATHLEEN A DRAGOVICH
K972494 10/01/1997 DEPUY DUPONT ABSORBABLE SET SCREW DEPUY, INC. SALLY FOUST
K972832 10/21/1997 PROVISION SURGICAL HELMET SYSTEM DEPUY, INC. CHERLLY K HASTINGS
K972778 10/08/1997 DEY VIAL SODIUM CHLORIDE 3% DEY LABORATORIES, INC. ALLAN S KAPLAN
K972021 10/31/1997 IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K973514 10/31/1997 ACTIVE INTACT PTH DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN WILLIS
K973177 10/09/1997 MAGO AUTOMATED EIA PROCESSOR DIAMEDIX CORP. LYNNE STIRLING
K971877 10/08/1997 LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR DIDECO S.P.A. BARRY SALL
K972659 10/17/1997 DONG BANG ACUPUNCTURE NEEDLES DONG BANG, U.S.A. SUE KIM
K972658 10/17/1997 MAGI ACUPUNCTURE NEEDLES DONG BANG, U.S.A. SUE KIM
K973051 10/30/1997 DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS DRAEGER MEDICAL, INC. JAMES J BRENNAN
K972848 10/30/1997 NARKOMED MRI ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. JAMES J BRENNAN
K971198 10/03/1997 BABYTHERM 8004 BABYTHERM 8010 DRAGER, INC. HERALD KNEUER
K973047 10/02/1997 ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD
K972847 10/07/1997 KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) EASTMAN KODAK COMPANY ROBERT L HILLER
K972745 10/21/1997 TITANIUM HEMOSTATIC CLIP EISNER USA, INC. ELLEN HENVE-UNEPP
K971588 10/24/1997 EVI SUTURED-CLIP APPLIER ELECTIVE VASCULAR INTERVENTION INC. (EVI) MICHAEL A DANIEL
K972514 10/03/1997 LASEREX LP1532 PHOTOCOAGULATOR ELLEX MEDICAL PTY. LTD. KEITH R DEGENHARDT
K972826 10/15/1997 ESTEEM 1.5T MRI SYSTEM ELSCINT MR, INC. ELIZABETH F LOWDER
K973054 10/01/1997 ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS EMD CHEMICALS INC. ANNA G BENTLEY
K972558 10/07/1997 BIPOLAR SCISSORS ENABLE MEDICAL CORP. MICHAEL D HOOVEN
K972353 10/28/1997 ERCO-RIBBON ERCONS, INC. YAKOV ALTSHULER
K972872 10/28/1997 DERMA K LASER SYSTEM ESC MEDICAL SYSTEMS LTD. ZVI LADIN
K972028 10/24/1997 DERMASCAN SURGICAL LASER SCANNER ESC MEDICAL SYSTEMS LTD. ZVI LADIN
K972892 10/02/1997 CAVIT-LC ESPE GMBH & CO. KG. BARBARA WAGNER-SCHUH
K972578 10/01/1997 ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC. IVAN S PLACKO
K973173 10/29/1997 POWERSTAR BIPOLAR SCISSORS ETHICON, INC. GREGORY R JONES
K971464 10/29/1997 IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT EURO-DIAGNOSTICA AB KARL A POSSELT
K971689 10/29/1997 IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT EURO-DIAGNOSTICA AB KARL A POSSELT
K971690 10/29/1997 IMMUNOSCAN PR3-ANCA EURO-DIAGNOSTICA AB KARL A POSSELT
K972130 10/09/1997 DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR FAIRMONT MEDICAL JOANN MCBAIN
K972885 10/30/1997 SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 FISHER & PAYKEL ELECTRONICS LTD. CHRIS MANDER
K971131 10/03/1997 FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K972836 10/22/1997 ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS G. PREMJEE (USA), INC. SUSAN D GOLDSTEIN-FALK
K970233 10/08/1997 GELBFISH ENDO-VAC SYSTEM GARY A. GELBFISH ROBERT L SHERIDAN
K973343 10/21/1997 HYDROFLEX GC AMERICA, INC. TERRY L JORITZ
K964617 10/03/1997 GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS DAVID DUERSTELER
K973039 10/16/1997 LEGACY/LEGACY-D TABLE GE MEDICAL SYSTEMS LARRY A KROGER
K973368 10/17/1997 STRAIT'MAP OPTION GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K973179 10/30/1997 FEMINIQUE SONIC HAIR REMOVER GLOBAL TV CONCEPTS, LTD. SAMIA N RODRIGUEZ
K973174 10/30/1997 SONIQUE HAIR REMOVER GLOBAL TV CONCEPTS, LTD. SAMIA N RODRIGUEZ
K963967 10/31/1997 GLYCAR PERICARDIAL PATCH GLYCAR, INC. DIRK A FRATER
K963368 10/31/1997 GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE GLYCAR, INC. BERTRAM HUDSON
K972815 10/08/1997 PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT GRACE MEDICAL, INC. ANTHONY D PRESCOTT
K972156 10/16/1997 QUIX RAPID E. COLI O157 STRIP TEST GUARDIAN SCIENTIFIC, CORP. KATHRYN B POWERS
K972661 10/03/1997 EYE SPHERE, CONFORMERS GULDEN OPHTHALMICS THOMAS COCKLEY
K973574 10/24/1997 DURALASTIC ANATOMICAL MALAR IMPLANT HANSON MEDICAL, INC. ERIK HANSON
K973572 10/21/1997 KELOCOTE SCAR GEL AND KELOCOTE LASER GEL HANSON MEDICAL, INC. ERIK HANSON
K962829 10/16/1997 HARMAC BALLOON ANGIOGRAPHIC CATHETER HARMAC MEDICAL PRODUCTS, INC. JOSEPH M KNOIECZNY
K963335 10/16/1997 HARMAC BALLOON WEDGE PRESSURE CATHETER HARMAC MEDICAL PRODUCTS, INC. JOSEPH KONIECZNY
K962833 10/15/1997 HARMAC TEMPORARY PACING CATHETER WITH BALLOON HARMAC MEDICAL PRODUCTS, INC. JOSEPH M KONIECZNY
K963136 10/10/1997 PACER MODEL 100 INFUSION CONTROLLER HEALTH WATCH, INC. JOHN D GREENBAUM
K972570 10/01/1997 HEARTPORT INTRODUCER SHEATH HEARTPORT, INC. MARIANNE C DRENNAN
K972229 10/16/1997 IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM HEARTWARE, INC. CYNTHIA A SINCLAIR
K972617 10/01/1997 HELAX-VISIR HELAX AB JAN TORNQVIST
K973316 10/01/1997 REP SPE VIS-60/40 KIT HELENA LABORATORIES PAT FRANKS
K972274 10/27/1997 SPIFE HELENA LABORATORIES PAT FRANKS
K971733 10/02/1997 2 BOND 2 HERAEUS KULZER, INC. SHARON PARKER
K973466 10/24/1997 HANAULUX BLUE 75 AND HANAULUX BLUE 120 HERAEUS MED GMBH MARK SCHULZ
K970456 10/03/1997 HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM HEWLETT-PACKARD GMBH MIKE HUDON
K972277 10/21/1997 DIGIFLEX SURGICAL GLOVES HMS SERVICES, INC. HARSH AGGARWAL
K972727 10/10/1997 CBALK-1000 BLADE HOWARD INSTRUMENTS, INC. JACK W HOWARD
K972551 10/29/1997 ARTISAN PULSE LAVAGE SYSTEM HOWMEDICA CORP. MARGARET F CROWE
K963502 10/28/1997 CSCO FOREHEAD FIXATION SYSTEM HOWMEDICA CORP. KRISTYN R WASKI
K972752 10/21/1997 DURACON CONVERSION METAL BACKED PATELLA HOWMEDICA CORP. MARGARET F CROWE
K972792 10/16/1997 DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS HOWMEDICA CORP. FRANK MAAS
K972864 10/29/1997 DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS HOWMEDICA CORP. FRANK MAAS
K972863 10/29/1997 DURATION STABILIZED UHMWPE KNEE COMPONENTS HOWMEDICA CORP. FRANK MAAS
K972813 10/09/1997 GAMMA LOCKING NAIL SYSTEM HOWMEDICA CORP. VIVIAN KELLY
K972811 10/06/1997 HOWMEDICA FULLY THREADED SCREWS HOWMEDICA CORP. VIVIAN KELLY
K970912 10/01/1997 LEIBINGER SELF-DRILLING SCREW HOWMEDICA LEIBINGER, INC. KRISTYN WASKI
K973292 10/20/1997 I-STAT SYSTEM I-STAT CORP. IMANTS R LAUKS
K972712 10/01/1997 CORE RESISTANT HUBER INFUSION SETS ICU MEDICAL, INC. ARLENE DUTCHIK
K972879 10/15/1997 ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION IMATRON, INC. J. A. CODUTO
K972506 10/01/1997 INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR INFINITECH, INC. ALAN T BECKMAN
K972622 10/09/1997 STRAIGHT-IN BONE SCREW FIXATION SYSTEM INFLUENCE, INC. MARK D KRAMER
K972684 10/10/1997 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM INNERDYNE, INC. RICK GAYKOWSKI
K973294 10/03/1997 INNOVATOME MICROKERATOME INNOVATIVE OPTICS, INC. LARRY HICKS
K973283 10/21/1997 ALGINATE/ZINC WOUND DRESSING INNOVATIVE TECHNOLOGIES LTD. PRISCILLA WHITEHEAD COX
K973312 10/22/1997 TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING INNOVATIVE TECHNOLOGIES LTD. PRESCILLA WHITEHEAD COX
K973006 10/20/1997 QUANTA LITE B2 GPI IGA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K973014 10/20/1997 QUANTA LITE B2GPI IGM INOVA DIAGNOSTICS, INC. BRYS C MYERS
K963858 10/21/1997 FEMASSIST URINARY DEVICE INSIGHT MEDICAL CORP. ROBERT W SCHAEFER
K973464 10/22/1997 QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K973253 10/30/1997 ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE INTERNATIONAL MEDICAL PRODUCTS, INC. JEFFREY R SHIDEMAN
K972842 10/30/1997 INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE INTERPORE INTL. DAVID P BALDING
K972923 10/27/1997 SUPER SILIPLUGS EAR PLUGS INTERVIEW MEDICAL TECHNOLOGY CORP. LOU MATSON
K972922 10/08/1997 VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K INTERVIEW MEDICAL TECHNOLOGY CORP. LOU MATSON
K972143 10/16/1997 MOA BONE / M-SPHERE IOP, INC. JASON MALECKA
K973022 10/20/1997 ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 ISLAND BIOSURGICAL, INC. HUNTER A MCKAY
K973234 10/27/1997 MIDAS TOUCH ELECTROSURGICAL ELECTRODE ITI MEDICAL TECHNOLOGIES, INC. ROGER WERNE
K972648 10/30/1997 SONICSYS INLAY IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K972933 10/27/1997 VOX/BASE FOR WINDOWS J-MAC SYSTEM, INC. SHEILA W PICKERING
K971649 10/29/1997 KSEA ARTHROPUMP PLUS KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K972926 10/08/1997 MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K972844 10/03/1997 TEMP BOND CLEAR KERR DENTAL MATERIALS CENTER WILLIAM R PIKE
K955243 10/23/1997 BARIAIR KINETIC CONCEPTS, INC. WILLIAM H QUIRK
K963914 10/08/1997 CM & CM DS-7 KONICA MEDICAL CORP. RUSSELL D MUNVES
K963913 10/08/1997 MD100 & MM150 KONICA MEDICAL CORP. RUSSELL D MUNVES
K972984 10/29/1997 LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE LERNER MEDICAL, INC. MICHAEL POLLACK
K972760 10/22/1997 LINK, ACETABULAR REVISION MESH CUP LINK AMERICA, INC. DOUGLAS W STUART
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K964434 10/09/1997 SD-970EMS ELECTRICAL MUSCULAR STIMULATOR SKYLARK DEVICE CO., LTD. GEORGE K.C. CHEN
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K973391 10/03/1997 CHEMMATE KAPPA VENTANA MEDICAL SYSTEMS, INC. KATHLEEN WINDALL
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K940583 10/20/1997 VENTANA CD45 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. KURT REINHARDT
K973345 10/29/1997 MATRIX PLUS MULTI-CALIBRATOR KIT VERICHEM LABORATORIES, INC. ANTHONY J DIMONTE
K972880 10/22/1997 MDP2000 MEDICAL DATA PROCESSOR VIDCO, INC. BRADLEY COHEN
K972200 10/20/1997 ANEUVYSION VYSIS RUSSEL K EVANS
K964880 10/16/1997 VARI-ANGLE HIP SCREW (VHS) SYSTEM WALTER ABENDSCHEIN, M.D. WALTER ABENDSCHEIN
K973074 10/06/1997 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR WATERS CORPORATION VIRGINIA L CORBIN
K972621 10/24/1997 PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) WEMBLEY RUBBER PRODUCTS (M) SDN BHD CHOW YUE WAH
K971375 10/31/1997 GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE WILSON GREATBATCH TECHNOLOGIES, INC. GARY J SFEIR
K972770 10/21/1997 ADVANCE ULTRA-CONGRUENT TIBIAL INSERT WRIGHT MEDICAL TECHNOLOGY, INC. DAN REGAN
K972641 10/09/1997 DUAL OFFSET PERFECTA IMC HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. KIM TOMPKINS
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K971056 10/03/1997 MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION WRIGHT MEDICAL TECHNOLOGY, INC. CRISTIE MANUEL
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