FDA 510(k) Applications Received During June, 1997

FDA 510(k) Number Submission Date Device Name Applicant Contact
K972355 06/25/1997 3M AURORA SYSTEM 3M COMPANY LISA A WEIK
K972245 06/16/1997 TOM CAT F.L., TOM CAT S.L. A & A MEDICAL, INC.
K972383 06/26/1997 EASY-JET DEVICE A. STEIN - REGULATORY AFFAIRS CONSULTING AHAVA STEIN
K972118 06/05/1997 VERA PDN AALBA DENT, INC. ROBERT W BAUER
K972232 06/16/1997 ABBOTT AXSYM FOLATE ABBOTT LABORATORIES LAURA L GRANITZ
K972354 06/24/1997 ABBOTT CELL-DYN 3200 SYSTEM ABBOTT LABORATORIES SUE E LUPTOVIC
K972195 06/11/1997 POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. WOLFE BIRKIE
K972177 06/10/1997 POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. WOLFE BIRKIE
K972183 06/10/1997 DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL ACE MEDICAL CO. KATHLEEN A DRAGOVICH
K972100 06/04/1997 VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) ADVANCED CARE MEDICAL PRODUCTS STEVEN FAINSZTEIN
K972332 06/23/1997 AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM AESCULAP, INC. MARY ELLEN HOLDEN
K972309 06/20/1997 JM-102 JAUNDICE METER AIR-SHIELDS, INC. T. WHIT ATHEY
K972213 06/12/1997 MS-700 ALAN S. LEE ALAN S LEE
K972084 06/04/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972089 06/04/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972086 06/04/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972246 06/16/1997 SPECTACLE FRAMES (NON-PRESCRIPTION) ALIMAR TRADING, INC. AULIO C GIRON
K972291 06/19/1997 ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES ALLEGIANCE HEALTHCARE CORP. MARYALICE SMITH
K972203 06/11/1997 BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT ALLIED HEALTHCARE PRODUCTS, INC. STANLEY E FRY
K972325 06/23/1997 PULSEMASTER 1000 ST DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. JOHN G SULEWSKI
K972221 06/13/1997 K 15 AUDIOMETER AMERICAN ELECTROMEDICS CORP. MICHAEL T PIENIAZEK
K972091 06/04/1997 AMS FOREIGN BODY EXTRATOR AMERICAN MEDICAL SYSTEMS, INC. LISA L PRITCHARD
K972187 06/10/1997 BOUFFANT CAP AMERICAN SEAL CO. JOSEPH TUNG
K972227 06/13/1997 SHOE COVER AMERICAN SEAL CO. JOSEPH TUNG
K972382 06/26/1997 UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL ARROWS CO., LTD. YOSHIMASA OGOSHI
K972952 06/20/1997 AUREBOND 51 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972938 06/20/1997 AURECAST 10 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972936 06/20/1997 AURECAST 2 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972937 06/20/1997 AURECAST 4 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972941 06/20/1997 AURECAST 74 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972942 06/20/1997 AURECAST 83 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972943 06/20/1997 AURECAST 92 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972939 06/20/1997 AURECAST BIO 59PF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972940 06/20/1997 AURECAST BIO 69PF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972319 06/20/1997 AURECAST GF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J D DAVIS
K972946 06/20/1997 AURELUX 77 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972949 06/20/1997 AURELUX BIO Y85PF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972945 06/20/1997 AURENORM 68 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972950 06/20/1997 HIPALLAUR 19 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972951 06/20/1997 HIPALLAUR 51 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. WEST
K972953 06/20/1997 PALAUREX 76KF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972954 06/20/1997 PALAUREX 78 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972955 06/20/1997 PALCERAM 56 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972956 06/20/1997 PALCERAM 82SF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972159 06/09/1997 FENWAL 40 MICRON TRANSFUSION FILTER BAXTER HEALTHCARE CORP. MARY E SNYDER
K972404 06/26/1997 VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC JOHN SCHALAGO
K972254 06/16/1997 FIRST MIDCATH CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. C.J. WELLE
K972264 06/17/1997 FIRST MIDCATH CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. C.J. WELLE
K972262 06/17/1997 FIRST PICC CATHETER BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. C.J. WELLE
K972263 06/17/1997 FIRST PICC CATHETER WITH DUAL LUMENS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. C.J. WELLE
K972758 06/16/1997 BACTEC MYCO/F-SPUTA CULTURE VIALS BECTON DICKINSON MICROBIOLOGY SYSTEMS COLLEEN ROHRBECK
K972098 06/04/1997 FOSFOMYCIN, 200 MG, SENSI-DISC BECTON DICKINSON MICROBIOLOGY SYSTEMS VIRGINIA C WEINKNECHT
K972075 06/03/1997 VACUTAINER BRAND PPT PLASMA PREPARATION TUBE BECTON DICKINSON VACUTAINER SYSTEMS JOHN SCHALAGO
K972316 06/20/1997 OPUS D-DIMER BEHRING DIAGNOSTICS, INC. RUTH FORSTADT
K972116 06/05/1997 VON WILLEBRAND REAGENT BEHRING DIAGNOSTICS, INC. PAUL L ROGERS
K972284 06/19/1997 FLUID MANAGEMENT SYSTEM BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K972299 06/19/1997 BERGEN MODEL 500 ELECTROSURGERY GENERATOR BERGEN MFG. ROGER OOSTEN
K972131 06/06/1997 BREATH ACE BREATHFRESHENER BEYOND 21ST CENTURY, INC. HEMANT K THAKUR
K972029 06/02/1997 BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM BICON, INC. VINCENT MORGAN
K972417 06/27/1997 THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM BICON, INC. VINCENT J MORGAN
K972244 06/16/1997 NT2000 BIO-MEDICAL RESEARCH, LTD. GREG SHIPP
K972024 06/02/1997 CODA AUTOMATED EIA ANALYZER BIO-RAD JOHN W NELSON
K972174 06/09/1997 LYPHOCHEK REMEDI CONTROL BIO-RAD DONNA CHAPMAN
K972167 06/09/1997 PLASMA CATECHOLAMINE KIT BIOANALYTICAL SYSTEMS, INC. STEPHEN GEARY
K972403 06/26/1997 BTI CORTICAL BONE SCREWS BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K972313 06/20/1997 THE MAESTRO SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. R. STEVEN BOGGAN
K972064 06/03/1997 MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV BIOLOGICAL CONTROLS, INC. GARY D MESSINA
K972384 06/26/1997 AQ ONE STEP COCAINE TEST BIONIKE LABORATORIES, INC. JANIS FREESTONE
K972129 06/06/1997 CHLAMYDIATROL AG BLACKHAWK BIOSYSTEMS, INC. CAROLE POLITO
K972433 06/30/1997 CEDIA DIGOXIN CALIBRATORS BOEHRINGER MANNHEIM CORP. YVETTE LLOYD
K972162 06/09/1997 ELECSYS CA 125 II BOEHRINGER MANNHEIM CORP. LEEANN CHAMBERS
K972235 06/16/1997 PRECICONTROL TUMOR MARKER 1 AND 2 BOEHRINGER MANNHEIM CORP. LEEANN CHAMBERS
K972048 06/02/1997 ACCURUN 117 HBEAG POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K972307 06/19/1997 ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K972096 06/04/1997 BIVALVE NASAL SPLINT BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972082 06/04/1997 CUSTOM NASAL SPLINT BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972151 06/09/1997 DOYLE COMBO NASAL AIRWAY SPLINT BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972076 06/03/1997 EPI-MAX EPISTAXIS CATHETER BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972077 06/03/1997 EPI-STOP EPISTAXIS CATHETER BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972317 06/20/1997 MONTGOMERY THYROPLASTY IMPLANT SYSTEM BOSTON MEDICAL PRODUCTS, INC. ROSINA ROBINSON
K972092 06/04/1997 NASAL AIRWAY SPLINT BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972060 06/02/1997 NASAL SEPTAL BUTTON BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972078 06/03/1997 POST-STOP EPISTAXIS CATHETER BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K972113 06/05/1997 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL BOSTON SCIENTIFIC CORP. LEO BASTA
K972357 06/25/1997 BLUE MAX - 20 BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. MARY P LEGRAW
K972311 06/20/1997 MODEL 20 BIPOLAR COAGULATOR BOSTON SURGICAL PRODUCTS, INC. CHARLES VASSALLO
K972350 06/24/1997 MODEL 50 BIPOLAR COAGULATOR BOSTON SURGICAL PRODUCTS, INC. CHARLES VASSALLO
K972371 06/25/1997 ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR BRASAMERICA MEDICAL EQUIPMENT, INC. SUSAN D GOLDSTEIN-FALK
K972022 06/02/1997 ZAK-2000 CARDIO SYSTEMS, INC. MIKE A SCANLAN
K972320 06/23/1997 BIOZ SYSTEM & BIOZ PORTABLE CARDIODYNAMICS INTERNATIONAL CORP. JAMES BARLEY
K972073 06/03/1997 TOTAL BILIRUBIN REAGENT CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K972138 06/06/1997 CARR RIGID CONTAINER SYSTEM CARR METAL PRODUCTS, INC. ALAN BOOKER
K972020 06/02/1997 OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K972446 06/30/1997 PEDO CUSH PEDO CUDDLE CAVITY FREE KIDS, INC. VACHAREE S PETERSON
K972210 06/11/1997 RESECTOSCOPE SAFETY SHEATH CONCEPTUS, INC. CINDY DOMECUS
K972080 06/03/1997 QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 CONSOLIDATED TECHNOLOGIES, INC. VIPIN D SHAH
K972146 06/09/1997 QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS CONSOLIDATED TECHNOLOGIES, INC. VIPIN D SHAH
K972442 06/30/1997 CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 CONTINENTAL X-RAY CORP. OSCAR KHUTORYANSKY
K972062 06/03/1997 CONVATEC NON-ADHESIVE DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIENNE MCNALLY
K972449 06/30/1997 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL COPAN ITALIA SPA CYNTHIA A SINCLAIR
K972448 06/30/1997 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL COPAN ITALIA SPA CYNTHIA A SINCLAIR
K972110 06/05/1997 CORDIUS ENDEAVOR (VARIOUS) CORDIS CORP. ARIEL MACTAVISH
K972257 06/17/1997 N-ASSAY TIA ANTITHROMBIN III TEST KIT CRESTAT DIAGNOSTICS, INC. MARY REES
K972428 06/27/1997 EXTRAWEAR, GENTLEMEN'S CHOICE CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K972430 06/27/1997 EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K972429 06/27/1997 INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K972427 06/27/1997 INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K972287 06/19/1997 DADE TRU-LIQUID BILIRUBIN CONTROL DADE INTL., INC. RADHA GOOLABSINGH
K972180 06/10/1997 DRIED GRAM-NEGATIVE MIC/COMBO PANELS DADE MICROSCAN, INC. SHAROLYN LENTSCH
K972139 06/06/1997 ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP DAVIS & GECK, INC. STEPHEN J TAMSETT
K972153 06/09/1997 ALTERNATING PRESSURE AIR FLOTATION MATTRESS DECUBITI CONCEPTS, INC. JEAN ROZINT
K972234 06/16/1997 RCT GEL ROOT CANAL THERAPY GEL DENTSPLY INTL. P. JEFFERY LEHN
K972336 06/23/1997 DERMAMEND HYDROGEL GAUZE DRESSING DERMARX CORP. MARYANNE CARROLL
K972152 06/09/1997 DEVMED STEPPING AND STABILIZING SYSTEM DEVMED CORP. GREG WIITA
K972337 06/23/1997 DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K972414 06/27/1997 FRESHCELLS DIAGNOSTIC HYBRIDS, INC. JAMES L BROWN
K972095 06/04/1997 IMMULITE 2000 PSA DIAGNOSTIC PRODUCTS CORP. ROBERT M DITULLIO
K972021 06/02/1997 IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K972526 06/26/1997 METHADONE EIA ASSAY DIAGNOSTIC REAGENTS, INC. YUH-GENG TSAY
K972314 06/20/1997 PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM DIAMETRICS MEDICAL, LTD. KARIMA HEBRI
K972059 06/02/1997 QUIKPAC II ONE STEP COCAINE TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD
K972405 06/26/1997 QUIKPAC II ONE STEP OPIATE TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD
K972147 06/09/1997 PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2) DYNAMIC SYSTEMS, INC. DAVID R COURT
K972380 06/26/1997 KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) EASTMAN KODAK COMPANY NANCY BUTCHER
K972370 06/25/1997 RASCAL POWER CHAIR ELECTRIC MOBILITY CORP. LEE J FALGOUST
K972324 06/23/1997 LEKSELL STEREOTACTIC SYSTEM ELEKTA INSTRUMENT AB CAROL PATTERSON
K972072 06/03/1997 SURGITRON MODEL FFPF-EMC ELLMAN INTL., INC. FRANK LIN
K972054 06/02/1997 INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE EMPI CAROLYN M STEELE HUSTEN
K972450 06/30/1997 FLEXTIP GRASPER ENDIUS, INC. CYNTHIA J NOLTE
K972269 06/17/1997 DISPOSABLE PATIENT RETURN ELECTRODE ERBE USA, INC. MICHAEL A CLARK
K972353 06/24/1997 ERCO-RIBBON ERCONS, INC. YAKOV ALTSHULER
K972419 06/27/1997 TOENNIES NEUROSCREEN SYSTEM ERICH JAEGER, INC. D. GROTHEER
K972028 06/02/1997 DERMASCAN SURGICAL LASER SCANNER ESC MEDICAL SYSTEMS LTD. ZVI LADIN
K972412 06/26/1997 PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH ETHICON, INC. GREGORY R JONES
K972365 06/25/1997 COMPACT OR COMP-X EUROTEC, S.R.L. CHRISTIAN BONAZZI
K972157 06/09/1997 EXCEL AV STIM 1000 EXCEL TECH. LTD. JOHN R MUMFORD
K972700 06/18/1997 "EXMOOR" ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K972130 06/06/1997 DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR FAIRMONT MEDICAL JOANN MCBAIN
K972219 06/12/1997 ORTHOPEDIC PLATE SYSTEM FERGUSON MEDICAL FRANK FERGUSON
K972217 06/12/1997 ORTHOPEDIC SCREW SYSTEM FERGUSON MEDICAL FRANK FERGUSON
K972256 06/16/1997 FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS) FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K972140 06/06/1997 A1 ACOUSTIC RHINOMETER G.M. INSTRUMENTS LTD. E. W GREIG
K972266 06/17/1997 GALLINI COAXIAL INTRODUCER GALLINI U.S., LLC. PAUL L HAWTHORNE
K972399 06/26/1997 ADVANTAGE WINDOWS VOLUME RENDERING OPTION GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K972296 06/19/1997 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K972109 06/05/1997 SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER GENERAL SURGICAL INNOVATIONS CATHLEEN MANTOR
K972338 06/23/1997 PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30" X 30" BELT. GERIATRIC PRODUCTS, INC. E.J. SMITH
K972285 06/19/1997 GETTIG STYRL-JECT DELIVERY SYSTEM GETTIG PHARMACEUTICAL INSTRUMENT CO. KEVIN FEE
K972046 06/02/1997 FULL BODY RESTRAINT SYSTEM GILLEN INDUSTRIES JOHN GILLEN
K972376 06/25/1997 IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE GLENWOOD, LLC. JOHN I GRUEN
K972375 06/25/1997 IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE GLENWOOD, LLC. JOHN I GRUEN
K972424 06/27/1997 SILENTNITE GLIDEWELL LABORATORIES KEITH D ALLRED
K972202 06/11/1997 DEEG-LITE GRASS-TELEFACTOR PRODUCT GROUP JAMES S BRYAN
K972156 06/09/1997 QUIX RAPID E. COLI O157 STRIP TEST GUARDIAN SCIENTIFIC, CORP. KATHRYN B POWERS
K972142 06/06/1997 ACS HI-TORQUE ALL STAR 0.014" GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP. WAYNE R HOHMAN
K972290 06/19/1997 ACS HI-TORQUE RULER GUIDE WIRE GUIDANT CORP. SUE SILAVIN
K972198 06/11/1997 DENT-TEMP ACRYLIC HEALTH-DENT INTL., INC. JASHAN SETH
K972418 06/27/1997 HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) HEARTSTREAM, INC. CINDY PESTKA
K972229 06/13/1997 IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM HEARTWARE, INC. CYNTHIA A SINCLAIR
K972274 06/18/1997 SPIFE HELENA LABORATORIES PAT FRANKS
K972101 06/04/1997 SOLITAIRE HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K972348 06/24/1997 HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM HEWLETT-PACKARD CO. ROB BUTLER
K972111 06/05/1997 RUMORS DYNAMIC AIR THERAPY UNIT HILL-ROM, INC. EDWIN BILLS
K972277 06/18/1997 DIGIFLEX SURGICAL GLOVES HMS SERVICES, INC. HARSH AGGARWAL
K972108 06/05/1997 ALTA INTRAMEDULLARY ROD SYSTEM HOWMEDICA CORP. VIVIAN KELLY
K972401 06/26/1997 HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS HOWMEDICA CORP. MARGARET F CROWE
K972154 06/09/1997 COHEN DISTRACTOR HOWMEDICA LEIBINGER, INC. JOHN F DICHIARA
K972166 06/09/1997 GUERRERO - BELL DISTRACTOR HOWMEDICA LEIBINGER, INC. JOHN F DICHIARA
K972228 06/13/1997 MERIDIAN TITANIUM FEMORAL STEMS HOWMEDICA, INC. FRANK MAAS
K972361 06/25/1997 V40 ZIRCONIA FEMORAL HEADS HOWMEDICA, INC. FRANK MAAS
K972191 06/10/1997 DIGITIZER DIRECTOR (HSC025-01) HOWTEK, INC. RUSSELL LEONARD
K972173 06/09/1997 MEDI-SIS SYRINGE INFUSION SYSTEM I-FLOW CORP. ROBERT J BARD
K972426 06/27/1997 MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH IMAGYN MEDICAL, INC. DEBRA A RINDERER
K972163 06/09/1997 IMATION SE-196 LASER IMAGER IMATION CORP. STEPHEN G SLAVENS
K972145 06/06/1997 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM IMMUNO CONCEPTS, INC. ERIC S HOY
K972406 06/26/1997 ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM IMMUNO PROBE, INC. WILLIAM L BOTELER
K972366 06/25/1997 IMNET DICOM NETWORK AGENT IMNET SYSTEMS, INC. WI8LLIAM G BAIN
K972444 06/30/1997 3I INNOVATIVE IMPLANTS AND COVER SCREWS IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K972240 06/16/1997 IMTEC BIOBARRIER MEMBRANE IMTEC CORP. M.K. PATTERSON
K972023 06/02/1997 SLEEP-IN BONE SCREW SYSTEM INFLUENCE, INC. PETER A BICK
K972356 06/25/1997 INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER INNOVASIVE DEVICES, INC. STEPHEN PAGE
K972438 06/30/1997 INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER INNOVASIVE DEVICES, INC. STEPHEN PAGE
K972363 06/25/1997 IL TEST IRON INSTRUMENTATION LABORATORY CO. BETTY J LANE
K972261 06/17/1997 RIVETTI-LEVINSON INSTRALUMINAL SHUNT INTEGRA NEUROCARE LLC. LORI L HAYS
K972019 06/01/1997 PEFECT SHOT INTERNATIONAL IMAGING ELECTRONICS ROGER C CLAAR
K972397 06/26/1997 EZ SPRAY INTERTEX RESEARCH, INC. JOHN BULLOCK
K972141 06/06/1997 THE YELLOW IRIS URINALYSIS WORKSTATION INTL. REMOTE IMAGING SYSTEMS FRED H DEINDOERFER
K972143 06/06/1997 MOA BONE / M-SPHERE IOP, INC. JASON MALECKA
K972133 06/06/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. ANN M QUINN
K972435 06/30/1997 ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM JOHNSON & JOHNSON PROFESSIONALS, INC. MARY E GRAY
K972410 06/26/1997 IMPERVIOUS ISOLATION GOWN KENTRON HEALTH CARE, INC. NARI SADARANGANI
K972176 06/09/1997 HOME CARE BEAD BED KINETIC CONCEPTS, INC. WILLIAM H QUIRK
K972047 06/02/1997 KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE KLS-MARTIN L.P. ED RANSOM
K972409 06/26/1997 AG CHEMISTRY ANALYZER SYSTEM LANDMARK SCIENTIFIC, INC. T. WHIT ATHEY
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K972056 06/02/1997 STANDARD ENDOSCOPE LASER-OPTIK-SYSTEME GMBH & CO. KG MARC STRELOW
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K972258 06/17/1997 HI-CARE CLOSED SUCTION SYSTEM MALLINCKRODT MEDICAL MICHAEL B SCHOECK
K972199 06/11/1997 SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS MARQUETTE ELECTRONICS, INC. KRISTIN PABST
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K972207 06/12/1997 MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM MEDCOMP JEANNE M CUSH
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K972242 06/16/1997 REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM MEDTRONIC VASCULAR NORA K HADDING
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K972420 06/27/1997 LORENZ PECTUS SUPPORT BAR WALTER LORENZ SURGICAL, INC. DIANA PRESTON
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K972453 06/30/1997 XPS STRAIGHTSHOT MICRORESECTOR XOMED, INC. DAVID TIMLIN
K972027 06/02/1997 ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) ZHERMACK S.P.A. EVAN DICK
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