FDA 510(k) Applications Received During November, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K023807 11/14/2002 MODIFICATION TO ALKP ABBOTT LABORATORIES LINDA MORRIS
K023766 11/12/2002 ACON STREP A TWIST TEST DEVICE ACON LABORATORIES CO. EDWARD TUNG
K023946 11/27/2002 ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K023726 11/06/2002 TENS PRO 900 ACUMED MEDICAL SUPPLIES, LTD. RICHARD KEEN
K023772 11/12/2002 KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM ACUSON CORP. BOB LEIKER
K023711 11/04/2002 DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE ACUTE IDEAS CO. LTD. ALBERT CHEN
K023929 11/25/2002 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ADVANCED IMAGING RESEARCH, INC. RAVI SRINIVASAN
K023712 11/04/2002 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST ADVANTAGE DIAGNOSTICS CORP JANIS FREESTONE
K023788 11/13/2002 COLUMBUS (CR) TOTAL KNEE SYSTEM AESCULAP, INC. JOYCE KILROY
K023678 11/01/2002 DIMISIL SCAR GEL AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K023800 11/14/2002 VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 AIRCAST, INC. STEPHEN L KENNEY
K023693 11/01/2002 MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 AIREX INC. WILLIAM HASLEBACHER
K023936 11/26/2002 MODIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K023673 11/01/2002 AIRLIFE DEMAND NASAL CANNULA ALLEGIANCE HEALTHCARE CORP. SHARON NICHOLS
K023714 11/05/2002 REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL CORP. DON SELVEY
K023954 11/27/2002 ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES ALTUS MEDICAL, INC. KATHY MAYNOR
K023869 11/20/2002 'RAPIDTEC'-5M-MULTIPLE DIP TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K023885 11/21/2002 COMBI-SCREEN, MODELS 10SL AND 11SL ANALYTICON BIOTECHNOLOGIES AG DANIEL KAMM
K023815 11/15/2002 C-1805M ANODIA SYSTEMS THAD J OVERMYER
K023896 11/22/2002 C-1890 ANODIA SYSTEMS THAD OVERMYER
K023737 11/07/2002 INJECTOR ANTON MEYER & CO. LTD. THOMAS MEYER
K023769 11/12/2002 PREPARE ADMINISTRATION SET APPRO HEALTHCARE, INC. JOHN R SEMLER
K023890 11/21/2002 PREPARE CARTRIDGE APPRO HEALTHCARE, INC. JOHN R SEMLER
K023753 11/08/2002 VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E ARISTA LATINDO INDUSTRIAL LTD. P.T LINGA SUMARTA
K023754 11/06/2002 VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K023777 11/12/2002 ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 ARTHRONET MEDICAL, INC. CAROLINA SCHABER
K023729 11/06/2002 SIASCOPE II ASTRON CLINICA LIMITED E.J. Smith
K023905 11/22/2002 ATHENA PELVIC MUSCLE TRAINER ATHENA FEMININE TECHNOLOGIES, INC. BARBARA SARKIS
K023686 11/01/2002 AURORA MR-GUIDED INTERVENTIONAL SYSTEM AURORA IMAGING TECHNOLOGY, INC. ALAN OSLAN
K023934 11/26/2002 RAPID THERMAL EXCHANGE SYSTEM AVACORE TECHNOLOGIES, INC. CRAIG COOMBS
K023944 11/26/2002 BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST BAYER CORP. THOMAS F FLYNN
K023840 11/18/2002 ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K023841 11/18/2002 AMMONIA ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K023752 11/08/2002 BD INTEGRA SYRINGE BD PASQUALE AMATO
K023764 11/12/2002 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 BECKMAN COULTER, INC. LYNN WEIST
K023858 11/20/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023895 11/22/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN BECTON, DICKINSON & CO. MICHELLE B BANDY
K023955 11/27/2002 BD VIPER INSTRUMENT BECTON, DICKINSON & CO. COLLEN A KISTLER
K023703 11/04/2002 BI-OSTETIC BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K023705 11/04/2002 BICON TRANSITIONAL IMPLANT (BTI) SYSTEM BICON, INC. VINCENT J MORGAN
K023916 11/25/2002 BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K023913 11/25/2002 NEUROTECH BAXOLVE TYPE 294 BIO-MEDICAL RESEARCH, LTD. MICHELLE SAWYER
K023857 11/20/2002 PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 BIO-RAD CHRISTOPHER BENTSEN
K023810 11/15/2002 MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. JUDY SOKUA
K023694 11/01/2002 BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K023803 11/14/2002 MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS BIOTRONIK, INC. Jon Brumbaugh
K023721 11/05/2002 BONART ART-L2 LIGHT CURING UNIT BONART CO. LTD. ERIC L ONG
K023681 11/01/2002 RENEGADE STC 18 MICROCATHETER BOSTON SCIENTIFIC CORP. CHRISTINE M CAMERON
K023691 11/01/2002 BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC BOSTON SCIENTIFIC EPI TIMOTHY J JOHNSON
K023870 11/20/2002 FLEXIMA BILIARY CATHETER BOSTON SCIENTIFIC/MEDI-TECH NICHOLAS CONDAKES
K024192 11/20/2002 VECTORVISION FLUORO3D BRAINLAB, AG RAINER BIRKENBACH
K023820 11/15/2002 CO2 CLIP BREGAS AB PAUL KRILL
K023961 11/29/2002 SCOUT BOSS BURKE, INC. DUWAYNE E KRAMER JR.
K023750 11/08/2002 CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G CANON U.S.A., INC. SHEILA DRISCOLL
K023816 11/15/2002 CANON FULL AUTO TONOMETER TX-F CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION SHEILA DRISCOLL
K023728 11/06/2002 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR CANOPUS MEDICAL SUPPLY CO., LTD. RUBY LIN
K023689 11/01/2002 CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K023747 11/08/2002 PHASEAL CARMEL PHARMA AB. KJELL ANDREASSON
K023874 11/21/2002 SYSTEM 100 ULTRAFILTRATION CATHETER CHF SOLUTIONS, INC. AMY PETERSON
K023671 11/01/2002 AQUEOUS ACRYLIC DISPERSION 28% W/W CHX TECHNOLOGIES, INC. ROSS PERRY
K023732 11/06/2002 CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR CIBA VISION CORPORATION TERRINA WILDER
K023817 11/15/2002 SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 CLIO DESIGNS, INC. BERNARD FABRICANT
K023922 11/25/2002 COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 COAPT SYSTEMS, INC. SHELLEY TRIMM
K023914 11/25/2002 COAXIA FLOCONTROL CATHETER COAXIA INC GREGORY W SACHS
K023717 11/05/2002 SPERM WASH MEDIUM WITH GENTAMICIN CONCEPTION TECHNOLOGIES JOHN CORCORAN
K023731 11/06/2002 QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 CONSOLIDATED TECHNOLOGY CANDICE BETZ
K023850 11/19/2002 SYDNEY IVF EMBRYO BIOPSY MEDIUM COOK OB/GYN DEBBIE SCHMITT
K023937 11/26/2002 COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM COOK VASCULAR, INC. THOMAS J KARDOS
K023930 11/25/2002 COOPERSURGICAL OOCYTE RECOVERY NEEDLES COOPERSURGICAL, INC. JOSEPH M AZARY
K023907 11/25/2002 CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER CORDIS CORP. DONNA MARSHALL
K023710 11/04/2002 VISORB SWIFT CP MEDICAL MARY ANN GREENAWALT
K023768 11/12/2002 ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K023707 11/04/2002 A16 BLOOD FLOW MEASUREMENT SYSTEM D. E. HOKANSON, INC. D. EUGENE HOKANSON
K023868 11/20/2002 DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 DANNORITZER MEDICAL INSTRUMENTS DAGMAR S MASER
K023697 11/04/2002 STERI-MATE STERILIZABLE HANDPIECE DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K023776 11/12/2002 XENO III DENTAL ADHESIVE DENTSPLY INTL. P. JEFFERY LEHN
K023969 11/29/2002 REACTIVE SKIN DECONTAMINATION LOTION DEPT. OF THE ARMY RONALD E CLAWSON
K023835 11/18/2002 DEVEX MESH SYSTEM DEPUY ACROMED KAREN F JURCZAK
K023804 11/14/2002 MOSS MIAMI SPINAL SYSTEM PIN NUT DEPUY ACROMED LISA GILMAN
K023786 11/13/2002 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K023739 11/07/2002 GLUCOSE-SL-C ASSAY, MODEL 257-30 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K023748 11/08/2002 FLASH-LITE II LED DENTAL CURING LIGHT DISCUS DENTAL, INC. GARY L HOLLAR
K023794 11/13/2002 CONSTRAINED LINER ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K023757 11/08/2002 CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 ENDOCARE, INC. EBEN GORDON
K023683 11/01/2002 MULTI-STRAP FULL FACE MASK ENGINEERED MEDICAL SYSTEMS PAUL DRYDEN
K023886 11/21/2002 ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D ERBE USA, INC. JOHN TARTAL
K023812 11/15/2002 NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 ERBE USA, INC. JOHN TARTAL
K023796 11/13/2002 MS PAED-BABY BODY ERICH JAEGER GMBH EARL DRAPER
K023880 11/21/2002 CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER ETHICON, INC. PETER CECCHINI
K023740 11/07/2002 SYREX PRE-FILLED SYRINGE EXCELSIOR MEDICAL CORP. DAVID LUMIA
K023758 11/08/2002 BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) FCI OPHTHALMICS, INC. HILLARD W WELCH
K023723 11/05/2002 FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 FMS, FINAPRES MEDICAL SYSTEMS BV CHRISTINE EMANUEL
K023799 11/14/2002 FRIOS ALGIPORE FRIADENT GMBH CAROL PATTERSON
K023963 11/29/2002 ADHOC CLAW FUTURE MEDICAL SYSTEMS, INC. STEVE JANIN
K023751 11/08/2002 EXAJET GC AMERICA, INC. TERRY L JORITZ
K023814 11/15/2002 GRADIA DIRECT GC AMERICA, INC. TERRY L JORITZ
K023727 11/06/2002 TEMPORARY CEMENT-DC010002 GC AMERICA, INC. TERRY L JORITZ
K023932 11/26/2002 GE PHOTON ENERGY RECOVERY (PER) OPTION GE MEDICAL SYSTEMS F.I. HAIFA HEMY NEUMAN
K023943 11/26/2002 CT COLONOGRAPHY GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K023833 11/18/2002 GISH ARTERIAL FILTER WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K023888 11/21/2002 CIMOFLUOR GLOBAL DENTAL PRODUCTS, INC. JERRY L BARTICK
K023971 11/29/2002 VACUETTE TRACE ELEMENTS TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA Judi Smith
K023898 11/22/2002 GYNE IDEAS MINITAPE RP DEVICE GYNE IDEAS LTD. LOUIS MAZZARESE
K023834 11/18/2002 HL888 HEALTH & LIFE CO., LTD. SUSAN CHEN
K023854 11/19/2002 SAMARITAN AED, MODEL SAM-01 HEARTSINE TECHNOLOGIES, INC. WILLIAM J SMIRLES
K023761 11/08/2002 PLATELETWORKS, MODELS PW-A, PW-C HELENA LABORATORIES PATRICIA FRANKS
K023863 11/20/2002 AUTOMED 3000 INFUSION PUMP HELP TECHNOLOGIES ROBERT J BARD
K023784 11/12/2002 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K023901 11/22/2002 ALUMINA V40 FEMORAL HEADS HOWMEDICA OSTEONICS CORP. DEBRA BING
K023724 11/05/2002 DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K023692 11/04/2002 GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K023938 11/26/2002 MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 HUTCHINSON TECHNOLOGY, INC. THOMAS A DOLD
K023883 11/21/2002 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO I-FLOW CORP. SHANE NOEHRE
K023827 11/18/2002 PARAGON INFUSION SYSTEM WITH BOLUS I-FLOW CORP. SHANE NOEHRE
K023848 11/19/2002 MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: IGC-MEDICAL ADVANCES, INC. R. JERRY FROHLICH
K023949 11/27/2002 NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K023882 11/21/2002 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM IMPLEX CORP. ROBERT POGGIE
K023733 11/06/2002 COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR INGENJORSFIRMAN BJORN BERGDAHL AB BJORN BERGDAHL
K023887 11/21/2002 INION OTPS BIODEGRADABLE MINI PLATING SYSTEM INION LTD. HANNA MARTTILA
K023864 11/20/2002 PERFORMA STEREO INSTRUMENTARIUM CORP. IMAGING DIVISION BRIAN BRONCATTI
K023839 11/18/2002 HEMOSIL FACTOR V DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K023859 11/20/2002 SMARTTROAE INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K023808 11/14/2002 IRRIGATION SETS INTERNATIONAL MEDSURG CONNECTION MICHELE H VOVOLKA
K023908 11/25/2002 INTERPORE CROSS CEMENT RESTRICTOR INTERPORE CROSS INTL. PROSIE REY-FESSLER
K023824 11/18/2002 ALBUMIN COBALT BINDING TEST (ACB TEST) ISCHEMIA TECHNOLOGIES, INC. PETER CROSBY
K023925 11/25/2002 MARK I THERMAL IMAGER IX-DR, INC. WILLIAM J O'NEILL
K023828 11/18/2002 K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K023853 11/19/2002 K-ASSAY LP(A) CONTROLS KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K023924 11/25/2002 AUTOCON II 200 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY JAMES A LEE
K023704 11/04/2002 KSEA SCB ACC CONTROL KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K023917 11/25/2002 WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR KAWASUMI LABORATORIES, INC. DONALD R STONE
K023830 11/18/2002 AIROCIDE TI02 KES SCIENCE & TECHNOLOGY, INC JOHN HAYMAN, JR
K023770 11/12/2002 K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) KINETIKOS MEDICAL, INC. JOHN SPAMPINATO
K023866 11/20/2002 POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES KL-KEPONG RUBBER PRODUCTS SDN. BHD. YIM HOON PUNG
K023842 11/18/2002 CLEARFIL SE BOND PLUS KURARAY MEDICAL INC. MASAYA SASAKI
K023805 11/14/2002 LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 LAERDAL MEDICAL A/S MAGNE STEINSET
K023688 11/01/2002 LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER LEMAITRE VASCULAR, INC. JAMES ASHBY
K023920 11/25/2002 SKINTACT LEONHARD LANG GMBH ELAINE DUNCAN
K023787 11/13/2002 TAI-CHI AND MASTER ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K023960 11/29/2002 LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 LIDCO LTD. GREGORY SPELLER
K023832 11/18/2002 SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. JOHN E HUGHES
K023795 11/13/2002 PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) Lin-Zhi International, Inc. CHIU CHIN CHANG
K023701 11/04/2002 ANGIONEW-IV LIVING DATA TECHNOLOGIES CORPORATION SUSAN D GOLDSTEIN-FALK
K023838 11/18/2002 LUNEAU STERILE TONOMETER SEPARATION PRISMS LUNEAU SA JEAN N YOUNG
K023725 11/06/2002 HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K023789 11/13/2002 O.B. TAMPONS MCNEIL-PPC, INC. DIANA L.B. UHL
K023867 11/20/2002 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 11/25/2002 MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K023970 11/29/2002 QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J I HOLLANDER
K023735 11/07/2002 LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001 MEDSYS, S.A. JEFF MORGAN
K023797 11/14/2002 LAURAIN DEWALD ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K023878 11/21/2002 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM MEDTRONIC VASCULAR FRED L BOUCHER
K023798 11/14/2002 MODIFICATION TO ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. EREZ NIMROD
K023956 11/27/2002 THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K023780 11/12/2002 DRI PRIMIDONE CALIBRATORS MICROGENICS CORP. LAKSHMI ANNE
K023892 11/22/2002 MILLEX VV, GV, AND HV SYRINGE FILTER UNITS MILLIPORE CORP. THOMAS BORROWS
K023966 11/29/2002 DISPOSABLE BI-POLAR CABLE MODERN MEDICAL EQUIPMENT MFG., LTD. ROGER STRUBE
K023771 11/12/2002 SYNAMPS2 NEUROSCAN ELVIRA GARCIA
K023962 11/29/2002 NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 NEW STAR LASERS, INC. DONALD V JOHNSON
K023719 11/05/2002 MP-1 MICRO PERIMETER NIDEK TECHNOLOGIES SRL ALDO COCCHIGLIA
K023702 11/01/2002 POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE NINGBO TIANSHUN RUBBER PRODUCTS CO., LTD. JANNA P TUCKER
K023952 11/27/2002 REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE NOBEL BIOCARE UAS INC KATHELEEN DRAGOVICH
K023899 11/22/2002 DUAL YELLOW LASER, MODEL D10B NORSELD PTY., LTD. ROGER W BARNES
K023682 11/01/2002 ENCLOSE ANASTOMOSIS ASSIST DEVICE NOVARE SURGICAL SYSTEMS, INC. DAVID W SCHLERF
K023676 11/01/2002 APPLANATION TONOMETER OPTILASA S.L. JOSE M BOBES
K023843 11/18/2002 SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE OPUS MEDICAL, INC. JAMES W HART
K023875 11/21/2002 VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K023876 11/21/2002 VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K023884 11/21/2002 MODIFICATION ORIA SPINAL SYSTEM ORTHOTEC, L.L.C. PATRICK BERTRANOU
K023677 11/01/2002 OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) OSMETECH ANDREW TUMMON
K023967 11/29/2002 PALOMAR Q-YAG ND:YAG LASER SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC. Marcy Moore
K023818 11/15/2002 FIBERFILL AGP PENTRON CLINICAL TECHNOLOGIES ANNMARIE TENERO
K023819 11/15/2002 FIBERFILL SGP PENTRON CLINICAL TECHNOLOGIES ANNMARIE TENERO
K023742 11/07/2002 SCULPTURE PLUS NANO-HYBRID COMPOSITE PENTRON LABORATORY TECHNOLOGIES ANNMARIE TENERO
K023871 11/20/2002 M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K023698 11/04/2002 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K023674 11/01/2002 PHILIPS DRUG CALCULATOR SOFTWARE PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K023749 11/08/2002 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) PHILIPS MEDICAL SYSTEMS J.P. OUELLETTE
K023785 11/12/2002 LUNG NODULE ASSESSMENT AND COMPARISON OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K023931 11/26/2002 PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A PHILIPS MEDICAL SYSTEMS, INC. MARKUS STACHA
K023877 11/21/2002 Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN PHILIPS ULTRASOUND, INC. LYNN HARMER
K023860 11/20/2002 MICROALBUMIN REAGENT SET AND CALIBRATORS POINTE SCIENTIFIC, INC. RON JAMISON
K023793 11/13/2002 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR PORTEX, INC. CINDY ENGELHARDT
K023851 11/19/2002 PRECIMED HIP SCREW SYSTEM PRECIMED, INC. BARBARA LYONS
K023790 11/13/2002 UCC DENTAL MATERIAL PRECIOUS CHEMICALS U.S.A., INC. EUGENE LIEBERSTEIN
K023831 11/18/2002 UCP DENTAL MATERIAL PRECIOUS CHEMICALS U.S.A., INC. EUGENE LIEBERSTEIN
K023700 11/04/2002 PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE PRECISION VASCULAR SYSTEMS, INC. RICK GAYKOWSKI
K023837 11/18/2002 LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA PRINCETON BIOMEDITECH CORP. JEMO KANG
K023734 11/07/2002 ARAMIS II DERMATOLOGICAL LASER QUANTEL MEDICAL ROGER W BARNES
K023763 11/08/2002 RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS RANDOX LABORATORIES, LTD. LYNNE HAMILTON
K023847 11/19/2002 HEMO-STREAM HEMODIALYSIS CATHETER SET REX MEDICAL SUSAN D GOLDSTEIN-FALK
K023813 11/15/2002 BIPOLAR FORCEPS RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K023846 11/19/2002 MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY RITA MEDICAL SYSTEMS KAREN FRISCHMEYER
K023918 11/25/2002 RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS RUSCH INTL. RICK LYKINS
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K023801 11/14/2002 FILM PROCESSOR, MODEL LIFE RAY PRO 1000 S.A.I.E.P. S.R.L. DOUG HALE
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K023912 11/25/2002 POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM SANREA HEALTHCARE PRIVATE LIMITED JOSEPH J E PEREIRA
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K023745 11/07/2002 SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G SECHRIST INDUSTRIES, INC. GREG GODFREY
K023923 11/25/2002 SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE SENORX, INC. AMY BOUCLY
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K023852 11/19/2002 STAIRFRIEND CURVED STAIRWAY CHAIRLIFT SERVICES INDUSTRIELS SAVARIA, INC. ANSIS M HELMANIS
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K023720 11/05/2002 SONOLINE ANTARES ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JUDI HOFFMAN
K023687 11/01/2002 SOMATOM EMOTION 6 CT SYSTEMS SIEMENS MEDICAL SYSTEMS, INC. PRAVEEN NADKARNI
K023680 11/01/2002 BIOBUCK CEMENT RESTRICTOR SMITH & NEPHEW, INC. DAVID HENLEY
K023921 11/25/2002 JET-X HA COATED HALF PINS SMITH & NEPHEW, INC. DAVID HENLEY
K023743 11/07/2002 SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM SMITH & NEPHEW, INC. JANET JOHNSON AKIL
K023791 11/13/2002 NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR SOFTFOCAL COMPANY, INC. ROBERT B MANDELL
K023783 11/12/2002 SOHNIKS SOHNIKS ENDOSCOPY, INC. MARC HOSKINS
K023759 11/08/2002 CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER SONOMEDICA SAILOR MOHLER
K023957 11/27/2002 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) SONOSITE,INC. MICHAEL A HOFFMAN
K023713 11/04/2002 SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 SONTRA MEDICAL INC. ALBERT FARINHA
K023722 11/05/2002 SAFETYWAND DISPOSABLE HANDPIECE SPINTECH, INC. DANIEL J MANELLI
K023716 11/05/2002 SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K023953 11/27/2002 ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE ST. GEORGE TECHNOLOGY, INC. VERNON WATKINS
K023715 11/05/2002 STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM STARMATRIX SDN BHD NGAN BOON SENG
K023765 11/12/2002 STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) STELLARTECH RESEARCH CORP. JAMES R SANTOS
K023836 11/18/2002 THE SUAD DEVICE STRONG DENTAL INC. CLYDE A TAKEGUCHI
K023856 11/19/2002 VISUALINE METHADONE DIPSTRIPTEST SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K023826 11/18/2002 SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K023862 11/20/2002 NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER SYNTHES (USA) VIKKI M HOFFMAN
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K023792 11/13/2002 CALIBRATION PACK, MODELS A9100-101S AND A9100-103S THERMO ORION PATRICK K CHIU
K023760 11/08/2002 CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
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K023706 11/04/2002 ULTROID HEMORRHOID MANAGEMENT SYSTEM ULTROID, LLC RONALD R NEWTON
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K023902 11/22/2002 SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE USGI MEDICAL, INC. JUDY F GORDON
K023684 11/01/2002 CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 VILEX, INC. ABRAHAM LAVI
K023939 11/26/2002 VELOCITY ADVANTAGE VISION CARE DEVICES, INC. CHET CRACCHIOLO
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K023718 11/05/2002 QUICKSET MIMIX BONE VOID FILLER WALTER LORENZ SURGICAL, INC. KACY ARNOLD
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K023903 11/22/2002 WILSON-COOK ENDOSCOPIC CLIPPING DEVICE WILSON-COOK MEDICAL, INC. MARGARET POSNER
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