FDA 510(k) Decisions During August, 1997  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K972355 08/29/1997 3M AURORA SYSTEM 3M COMPANY LISA A WEIK
K972245 08/06/1997 TOM CAT F.L., TOM CAT S.L. A & A MEDICAL, INC.
K972532 08/15/1997 AALBA GOLD SOLDER AALBA DENT, INC. VINCENT M BENETTI
K972632 08/15/1997 VERA PD SOLDER AALBA DENT, INC. VINCENT M BENETTI
K972118 08/15/1997 VERA PDN AALBA DENT, INC. ROBERT W BAUER
K972182 08/13/1997 ABBOTT STREP A CONTROLS ABBOTT DIAGNOSTICS GRACE LEMIEUX
K971152 08/12/1997 ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) ABBOTT LABORATORIES SHERRY HAIFLICH
K972838 08/15/1997 POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED) ABSOLUTE SYNTHETIC TECHNOLOGIES MALAYSIA SDN. BHD. WOLFE BIRKIE
K972756 08/01/1997 MODIFICATION OF EST CULTURE SYSTEM II - MYCO ACCUMED INTL., INC. CYNTHIA C KNAPP
K964689 08/18/1997 TRACCELL 2000 SLIDE MAPPING SYSTEM ACCUMED INTL., INC. JOHN MIERS
K972183 08/26/1997 DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL ACE MEDICAL CO. KATHLEEN A DRAGOVICH
K971878 08/08/1997 VANTAGE 2.1 EXSPECT ADAC LABORATORIES DENNIS W HENKELMAN
K970669 08/01/1997 AEROQUIP SAFESTART IV CATHETER AEROQUIP MEDICAL PRODUCTS CHRISTINA L THOMAS
K971828 08/12/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 ALEXANDER MFG. CO. KEN HEIMENDINGER
K972086 08/12/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 ALEXANDER MFG. CO. KEN HEIMENDINGER
K971827 08/12/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 ALEXANDER MFG. CO. KEN HEIMENDINGER
K971183 08/08/1997 GOLD FINGERS ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K972465 08/15/1997 ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. PAUL D SMOLENSKI
K971519 08/19/1997 ASSERACHROM TPA TEST KIT AMERICAN BIOPRODUCTS CO. ANDREW LOC B LE
K971540 08/14/1997 AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORD AMERICAN BIOSURGICAL, INC. MICHAEL SOCOLOFF
K971853 08/06/1997 ENDOVIEW SPPHIRE LENS SET AMERICAN MEDICAL DEVICES, INC. FRANK J TIGHE
K972091 08/29/1997 AMS FOREIGN BODY EXTRATOR AMERICAN MEDICAL SYSTEMS, INC. LISA L PRITCHARD
K971918 08/12/1997 AMERIGEL OINTMENT SATURATED WOUND DRESSING AMERX HEALTH CARE CORP. RON MADDIX
K971747 08/05/1997 AMPLAID 460 AMPLIFON S.P.A. DANIEL KAMM
K971929 08/06/1997 AMSINO URINARY LEG BAG AMSINO INTL., INC. RICHARD Y LI
K962777 08/06/1997 AMR MINI-LAPAROSCOPE APPLIED MEDICAL RESOURCES HOWARD V ROWE
K972966 08/21/1997 AXT 150M MANUAL COLLIMATOR (AXT 150M) APPLIED X-RAY TECHNOLOGIES, INC. HOWARD C THOMAS
K971830 08/14/1997 ACCU-PULSE CARBON DIOXIDE LASER SYSTEM ARGUS PHOTONICS GROUP KEVIN DICKENSON
K970769 08/28/1997 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR ARISTO MEDICAL LARRY LEPLEY
K962577 08/21/1997 ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER ARROW INTL., INC. THOMAS D NICKEL
K973063 08/26/1997 FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR ASPECT VISION CARE, LTD. MARTIN S KNOPF
K972938 08/25/1997 AURECAST 10 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972936 08/25/1997 AURECAST 2 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972937 08/25/1997 AURECAST 4 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972941 08/28/1997 AURECAST 74 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972942 08/28/1997 AURECAST 83 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972939 08/26/1997 AURECAST BIO 59PF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972940 08/26/1997 AURECAST BIO 69PF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K972319 08/26/1997 AURECAST GF AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J D DAVIS
K964017 08/05/1997 AFFINITY BLOOD PUMP SYSTEM AVECOR CARDIOVASCULAR, INC. DENNIS E STEGER
K971645 08/01/1997 REGANES SPINAL NEEDLE (VARIOUS) AVID N.I.T., INC. JOSEPH E HARMS
K972673 08/20/1997 AVL 9181 ELECTROLYTE ANALYZER AVL SCIENTIFIC CORP. RANDY BYRD
K970943 08/18/1997 GUIDELINE SYSTEM AXON INSTRUMENTS, INC. ANDREW L BLATZ
K970926 08/01/1997 DOUBLE LUMEN PICC B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K972454 08/08/1997 OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB, INC. DENNIS HAHN
K971998 08/29/1997 ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM BAYER CORP. GABRIEL J MURACA
K971958 08/20/1997 SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT BECKMAN INSTRUMENTS, INC. LUCINDA STOCKERT
K972819 08/13/1997 VIGIL TDM CONTROLS BECKMAN INSTRUMENTS, INC. LUCINDA STOCKERT
K970836 08/26/1997 TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS ANNA LONGWELL
K972758 08/08/1997 BACTEC MYCO/F-SPUTA CULTURE VIALS BECTON DICKINSON MICROBIOLOGY SYSTEMS COLLEEN ROHRBECK
K972469 08/27/1997 SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE BEECH MEDICAL PRODUCTS, INC. JOHN ROMANO
K971852 08/15/1997 AIR CONDUCTION HAEARING AIDS BELTONE ELECTRONICS CORP. ROBERT A KRATOCHVIL
K972299 08/27/1997 BERGEN MODEL 500 ELECTROSURGERY GENERATOR BERGEN MFG. ROGER OOSTEN
K971629 08/06/1997 PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED) BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K972029 08/18/1997 BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM BICON, INC. VINCENT MORGAN
K972609 08/06/1997 VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM BIO-RAD JOHN W NELSON
K972167 08/04/1997 PLASMA CATECHOLAMINE KIT BIOANALYTICAL SYSTEMS, INC. STEPHEN GEARY
K972403 08/29/1997 BTI CORTICAL BONE SCREWS BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K971500 08/18/1997 ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES JAMES P KULLA
K971870 08/19/1997 LACTOSORB TRAUMA PLATING SYSTEM BIOMET, INC. MARY VERSTYNEN
K971890 08/07/1997 RECOVERY PROTRUSIO CAGE BIOMET, INC. DEBORAH M MATARAZZO
K971938 08/25/1997 REPICCI II UNICONDYLAR KNEE BIOMET, INC. PATRICIA SANDBORN BERES
K964431 08/11/1997 ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) BIOMET, INC. PATRICIA S BERES
K972384 08/06/1997 AQ ONE STEP COCAINE TEST BIONIKE LABORATORIES, INC. JANIS FREESTONE
K972868 08/28/1997 TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL BIONOSTICS, INC. BRUCE R WILLIAMS
K970145 08/11/1997 PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) BIOSEARCH MEDICAL PRODUCTS, INC. MARTIN DYCK
K970388 08/14/1997 A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE BIOTRONIK, INC. Joseph J Schwoebel
K971930 08/14/1997 BK-N SEALING CAP BIOTRONIK, INC. KENNETH JENSEN
K972129 08/12/1997 CHLAMYDIATROL AG BLACKHAWK BIOSYSTEMS, INC. CAROLE POLITO
K972235 08/12/1997 PRECICONTROL TUMOR MARKER 1 AND 2 BOEHRINGER MANNHEIM CORP. LEEANN CHAMBERS
K972048 08/12/1997 ACCURUN 117 HBEAG POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K972307 08/07/1997 ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K971406 08/07/1997 ACCURUN 120 HAV IGG POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K971657 08/12/1997 ACCURUN 121 HAV IGM POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K972884 08/22/1997 ACCURUN 146 CMV IGM POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K972459 08/04/1997 RHINOCELL NASAL PACKINGS BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K971673 08/05/1997 40 CC SUMO BOSTON SCIENTIFIC CORP. LEO BASTA
K971906 08/20/1997 JEJENOSTOMY FEEDING TUBE BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K970296 08/29/1997 ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER BOSTON SCIENTIFIC CORP. DIANE JOHNSON
K972350 08/21/1997 MODEL 50 BIPOLAR COAGULATOR BOSTON SURGICAL PRODUCTS, INC. CHARLES VASSALLO
K971941 08/14/1997 AQUA SPRAY BOYD INDUSTRIES, INC. BRUCE V LIVINGSTON
K972371 08/19/1997 ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR BRASAMERICA MEDICAL EQUIPMENT, INC. SUSAN D GOLDSTEIN-FALK
K970927 08/26/1997 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM BRUNO INDEPENDENT LIVING AIDS, INC. WILLIAM W BELSON III
K972503 08/26/1997 CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K965066 08/11/1997 ARRHYTHMIA MAPPING SYSTEM (8100/8300) CARDIAC PATHWAYS CORP. EARLE L CANTY
K965140 08/18/1997 CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM CARDIOMETRICS, INC. ERIN DIGNAN
K965124 08/14/1997 LASETTE CELL ROBOTICS, INC. CONNIE WHITE
K972665 08/22/1997 CHASE BLOOD VESSEL SHUNT CHASE MEDICAL, INC. BERT DAVIS
K971021 08/12/1997 CHASE PHRENIC NERVE PAD CHASE MEDICAL, INC. BERT DAVIS
K970695 08/08/1997 ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) CHIRON DIAGNOSTICS CORP. DIANE C OATES
K964594 08/15/1997 VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) CIRCON CORP. ERVIN F TAYLOR, P.E.
K971026 08/14/1997 THE CIRCULATOR BOOT CIRCULATOR BOOT CORP. RICHARD S DILLON
K964831 08/08/1997 SURESCAN CLINICON CORP. ALAN BUNTING
K971881 08/12/1997 COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS COMEG ENDOSCOPY KAELYN HADLEY
K964229 08/19/1997 REGULUS NAVIGATOR COMPASS INTL., INC. DEBRAH A FISHER
K972628 08/27/1997 THERMOGARD & THERMOGARD PLUS ABC CONMED CORP. IRA D DUESLER
K971903 08/21/1997 SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER CONTINUUM BIOMEDICAL, INC. ROBERT S ANDERSON
K971879 08/14/1997 SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER CONTINUUM BIOMEDICAL, INC. ROBERT S ANDERSON
K972062 08/14/1997 CONVATEC NON-ADHESIVE DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIENNE MCNALLY
K962167 08/29/1997 BRONCHIAL BLOCKER COOK, INC. APRIL LAVENDER
K971837 08/06/1997 VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 COOPERSURGICAL, INC. DEBRA A PEKAR
K972449 08/20/1997 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL COPAN ITALIA SPA CYNTHIA A SINCLAIR
K972448 08/20/1997 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL COPAN ITALIA SPA CYNTHIA A SINCLAIR
K965237 08/27/1997 NURSES BOUFFANT CAP COPIOUMED INTL., INC. JANNA P TUCKER
K971316 08/27/1997 POLY (VINYL) EXAM GLOVE, POWDERED COPIOUMED INTL., INC. JANNA P TUCKER
K972110 08/14/1997 CORDIUS ENDEAVOR (VARIOUS) CORDIS CORP. ARIEL MACTAVISH
K964292 08/01/1997 N-ASSAY TIA APO A1 TEST KIT CRESTAT DIAGNOSTICS, INC.
K964294 08/01/1997 N-ASSAY TIA APO A1/B MULTI CALIBRATOR CRESTAT DIAGNOSTICS, INC.
K964296 08/01/1997 N-ASSAY TIA APO B TEST KIT CRESTAT DIAGNOSTICS, INC.
K972428 08/25/1997 EXTRAWEAR, GENTLEMEN'S CHOICE CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K972427 08/20/1997 INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK CUSTOM SERVICES INTL., INC. LILLIE C THOMAS
K972002 08/27/1997 CYNOSURE DERMATOLOGY LASER COOLING TIP CYNOSURE, INC. GEORGE CHO
K971737 08/08/1997 CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER CYNOSURE, INC. GEORGE CHO
K972782 08/15/1997 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY DADE INTL., INC. CAROLYN K GEORGE
K972180 08/01/1997 DRIED GRAM-NEGATIVE MIC/COMBO PANELS DADE MICROSCAN, INC. SHAROLYN LENTSCH
K970575 08/05/1997 ELECTRO-LITE ELITE POWERED WHEELCHAIR DAMACO RON HIGGINBOTHAM
K964738 08/14/1997 ELPHA 2000 CONTI DAN MED, INC. THOMAS SANDGAARD
K971044 08/25/1997 DASH, SULLIVAN, VITAL GARD DASH MEDICAL GLOVES, INC. ROBERT J SULLIVAN JR.
K972566 08/14/1997 DEXON VIOLET DAVIS & GECK, INC. VANADA JOHNSON
K971745 08/06/1997 BARD COMPOSITE PROSTHESIS DAVOL, INC., SUB. C.R. BARD, INC. JEANNETTE G CLOUTIER
K970014 08/06/1997 TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) DELPHI CONSULTING GROUP J. HARVEY KNAUSS
K970241 08/14/1997 DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS DEPUY, INC. SALLY FOUST
K970664 08/01/1997 GLUCOSE REAGENT DERMA MEDIA LAB., INC. CHARLES C ALLAIN, PH.D.
K971309 08/01/1997 UREA DERMA MEDIA LAB., INC. CHARLES C ALLAIN
K970660 08/12/1997 DERMAGRAN WOUND MANAGEMENT SYSTEM DERMA SCIENCES, INC. KENNETH A PALMER, PH.D.
K972152 08/15/1997 DEVMED STEPPING AND STABILIZING SYSTEM DEVMED CORP. GREG WIITA
K972337 08/08/1997 DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K972414 08/29/1997 FRESHCELLS DIAGNOSTIC HYBRIDS, INC. JAMES L BROWN
K970298 08/20/1997 DM-400 HOLTER ECG CASSETTE RECORDER DIAGNOSTIC MONITORING RAYMOND COHEN
K972095 08/22/1997 IMMULITE 2000 PSA DIAGNOSTIC PRODUCTS CORP. ROBERT M DITULLIO
K972835 08/28/1997 50NG/ML COCAINE METABOLITE CALIBRATOR DIAGNOSTIC REAGENTS, INC. YUH-GENG TSAY
K972526 08/04/1997 METHADONE EIA ASSAY DIAGNOSTIC REAGENTS, INC. YUH-GENG TSAY
K971855 08/18/1997 POTTY PAL AND FOREVER-DRY DIGITAL APPLICATIONS, INC. D. LYNN SHEPPARD
K970165 08/26/1997 EVITA 2 DURA DRAGER, INC. HAROLD KNEUER
K972059 08/28/1997 QUIKPAC II ONE STEP COCAINE TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD
K972405 08/08/1997 QUIKPAC II ONE STEP OPIATE TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD
K972571 08/20/1997 QUIKSTRIP ONE STEP OPIATES TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD
K972147 08/25/1997 PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2) DYNAMIC SYSTEMS, INC. DAVID R COURT
K971948 08/06/1997 PATIENT RESTRAINT E.M. ADAMS CO., INC. RICHARD K DONAHUE
K971894 08/20/1997 KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM EASTMAN KODAK COMPANY JUDITH A WALLACE
K971973 08/25/1997 KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER EASTMAN KODAK COMPANY HERMANN ARNDT
K970072 08/29/1997 OPUS S MODEL 4121 AND 4124 PACEMAKERS ELA MEDICAL, INC. CATHERINE G GOBLE
K971970 08/20/1997 EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. JON CAPAROTTA
K970990 08/25/1997 GYREX PRIMA 1TG 1.0T MRI SYSTEM ELSCINT MR, INC. ELIZABETH F LOWDER
K972054 08/14/1997 INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE EMPI CAROLYN M STEELE HUSTEN
K963290 08/06/1997 COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM ENDOSONICS CORP. ADAM SAVAKUS
K962548 08/05/1997 BSM BONE SUBSTITUTE MATERIAL KIT ETEX CORP. DOSUK D LEE
K971738 08/07/1997 ENDOPATH RESPOSABLE TROCAR SYSTEM ETHICON ENDO-SURGERY, INC. IVAN S PLACKO
K971475 08/21/1997 SHIELDED SURGICAL TROCAR ETHICON ENDO-SURGERY, INC. IVAN S PLACKO
K963899 08/22/1997 CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) EXMOOR PLASTICS LTD. BRIAN EAST
K972594 08/26/1997 METALPRIMER II GC AMERICA, INC. TERRY L JORITZ
K972046 08/15/1997 FULL BODY RESTRAINT SYSTEM GILLEN INDUSTRIES JOHN GILLEN
K971043 08/01/1997 GOLDEN EAGLE GOLDEN TECHNOLOGIES, INC. CHRIS MCCONNELL
K971050 08/01/1997 GOLDEN HAWK GOLDEN TECHNOLOGIES, INC. CHRIS MCCONNELL
K964219 08/11/1997 ZIP CONDOM CATHETER GOULTER MEDICAL, INC. DAVID W SCHLERF
K972970 08/27/1997 MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE GRAPHIC CONTROLS CORP. KATHLEEN SELOVER
K972142 08/25/1997 ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP. WAYNE R HOHMAN
K971305 08/11/1997 FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM GYNECARE INNOVATION CENTER GEORGE M SAVAGE
K963073 08/14/1997 HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET HARMAC MEDICAL PRODUCTS, INC. JOSEPH M KONIECZNY
K963336 08/14/1997 HARMAC THERMODILUTION CATHETER HARMAC MEDICAL PRODUCTS, INC. JOSEPH KONIECZNY
K971867 08/13/1997 ALICE 4R SYSTEM HEALTHDYNE TECHNOLOGIES, INC. TIMOTHY Y COWART
K971807 08/07/1997 IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL HEAR-RIGHT, INC. CRAIG BLOOMINGBURG
K972492 08/04/1997 BELL PROSTHESIS (PARTIAL) HEINZ KURZ DAGMAR S MASER
K972585 08/04/1997 AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR S MASER
K972812 08/28/1997 RAICHEM PREALBUMIN SPIA HEMAGEN DIAGNOSTICS, INC. JOSEPH M CALIFANO
K972710 08/15/1997 QUANTIFY(901) HEMATRONIX, INC. JAMES D LAPICOLA
K963481 08/11/1997 ANODYNE CC HEYER AMERICA, INC. ED RANSOM
K955477 08/06/1997 HI-TEC CO2 INSUFFLATOR TYPE 1300 HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ ULRICH HENZLER
K970636 08/26/1997 TOTALCARE., MODULAR THERAPY SYSTEM (MTS) HILL-ROM, INC. JAMES G CARPENTER
K972466 08/28/1997 SODIUM CHLORIDE INHALATION SOLUTION, USP HOLOPACK INTERNATIONAL, LP JOHN J BARTHE
K972467 08/28/1997 STERILE WATER FOR INHALATION, USP HOLOPACK INTERNATIONAL, LP JOHN J BARTHE
K972108 08/12/1997 ALTA INTRAMEDULLARY ROD SYSTEM HOWMEDICA CORP. VIVIAN KELLY
K972154 08/11/1997 COHEN DISTRACTOR HOWMEDICA LEIBINGER, INC. JOHN F DICHIARA
K972166 08/11/1997 GUERRERO - BELL DISTRACTOR HOWMEDICA LEIBINGER, INC. JOHN F DICHIARA
K972173 08/15/1997 MEDI-SIS SYRINGE INFUSION SYSTEM I-FLOW CORP. ROBERT J BARD
K972606 08/29/1997 PREGNACOL PREGNANCY TEST IMMUNOSTICS, INC. DAVID MYCOCK
K972444 08/26/1997 3I INNOVATIVE IMPLANTS AND COVER SCREWS IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K971705 08/06/1997 IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED IMPLEX CORP. GLENN N BYRD
K972240 08/26/1997 IMTEC BIOBARRIER MEMBRANE IMTEC CORP. M.K. PATTERSON
K963521 08/06/1997 IMZ TWIN PLUS - CYLINDER IMZ, GMBH ROBERT J SLOMOFF
K963520 08/12/1997 IMZ TWIN PLUS SCREW IMZ, GMBH ROBERT J SLOMOFF
K971950 08/01/1997 INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER INFINITECH, INC. ALAN T BECKMAN
K972023 08/25/1997 SLEEP-IN BONE SCREW SYSTEM INFLUENCE, INC. PETER A BICK
K972356 08/26/1997 INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER INNOVASIVE DEVICES, INC. STEPHEN PAGE
K971922 08/07/1997 INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER INNOVASIVE DEVICES, INC. STEPHEN M PAGE
K972861 08/19/1997 IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) INSTRUMENTATION LABORATORY CO. BETTY J LANE
K972363 08/15/1997 IL TEST IRON INSTRUMENTATION LABORATORY CO. BETTY J LANE
K972141 08/25/1997 THE YELLOW IRIS URINALYSIS WORKSTATION INTL. REMOTE IMAGING SYSTEMS FRED H DEINDOERFER
K970962 08/07/1997 JMS AV FISTULA NEEDLE JMS CO., LTD. T HIROSE
K970182 08/18/1997 DINAMAP COMPACT MONITOR JOHNSON & JOHNSON MEDICAL, INC. DARLENE T KORAB
K971982 08/12/1997 KARL STORZ MODEL 203020 20 EQUIMAT KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K972497 08/27/1997 KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES KARL STORZ ENDOSCOPY-AMERICA, INC. MARLENA A PIERCY
K971977 08/12/1997 KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. MARLENA ALLEN PIERCY
K972504 08/11/1997 MVM 3.3 MM MICROENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K970686 08/25/1997 ACCUTEMP-PROBE KENTEC MEDICAL, INC. MATT WILKEN
K972409 08/28/1997 AG CHEMISTRY ANALYZER SYSTEM LANDMARK SCIENTIFIC, INC. T. WHIT ATHEY
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