FDA 510(k) Applications Received During May, 1999

FDA 510(k) Number Submission Date Device Name Applicant Contact
K991588 05/07/1999 EMS SWISS ORTHOCLAST (EMS SA) ELECTRO MEDICAL SYSTEMS SHEILA HAMEON-HEYER
K991569 05/05/1999 HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 02 MARKETING GROUP, INC. LESTER FORD
K991541 05/03/1999 A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 A-MED SYSTEMS, INC. ROBERTA THOMPSON
K991762 05/24/1999 ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 A.P. TOTAL CARE, INC. LUIS P LEON
K991663 05/14/1999 AST/SGOT A.P. TOTAL CARE, INC. LUIS P LEON
K991665 05/14/1999 HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 A.P. TOTAL CARE, INC. LUIS P LEON
K991664 05/14/1999 LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 A.P. TOTAL CARE, INC. LUIS P LEON
K991761 05/24/1999 MAGNESIUM PRODUCT NO'S, 112-01, 112-02 A.P. TOTAL CARE, INC. LUIS P LEON
K991666 05/14/1999 TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 A.P. TOTAL CARE, INC. LUIS P LEON
K991605 05/10/1999 CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION ABBOTT LABORATORIES MICHELLE B ROEDING
K991839 05/28/1999 ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER ABX DIAGNOSTICS PAT AMTOWER
K991818 05/27/1999 ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 ACRYMED, INC. BRUCE GIBBINS
K991805 05/26/1999 ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION ACUSON CORP. WILLIAM WELCH
K991607 05/10/1999 VANTAGE 2.5 ADAC LABORATORIES DENNIS W HENKELMAN
K991630 05/11/1999 ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET ADVANCED MEDICAL SOLUTIONS GROUP PLC CHRIS OAKES
K991784 05/25/1999 RENEW LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K991675 05/17/1999 MODIFICATION OF: STERRAD BI TEST PACK ADVANCED STERILIZATION PRODUCTS KEVIN CORRIGAN
K991671 05/17/1999 HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM ADVANCED TECHNOLOGY LABORATORIES, INC. TERRENCE J SWEENEY
K991546 05/03/1999 AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
K991709 05/19/1999 BROWNE CIDEX OPA INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K991589 05/07/1999 FLEXIBLE VASCULAR CLAMP, VERSION 2 ALLEGIANCE HEALTHCARE CORP. PATRICIA SHARPE-GREGG
K991571 05/05/1999 10 CURIE IRDIUM 192, CSN00100-192 ALPHA-OMEGA SERVICES, INC. J. HARVEY KNAUSS
K991798 05/26/1999 ACME MEDICAL AESTHETIC ND:YAG LASER ALTUS MEDICAL MICHAEL LEVERNIER
K991626 05/11/1999 WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION ANALOGIC CORP. GARET VAN GENNEP
K991680 05/17/1999 SOFTINJECT ANDROSYSTEMS SRL ERMANNO GRECO
K991793 05/26/1999 ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM ANGIODYNAMICS, INC. TERI JUCKETT
K991540 05/03/1999 WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K991847 05/28/1999 THERMOFLEX SYSTEM ARGOMED, INC. RICHARD B KLEIN
K991686 05/17/1999 LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K991813 05/27/1999 UNI-GRAFT K DV VASCULAR GRAFT ATRIUM MEDICAL CORP. JOE DE PAOLO
K991576 05/06/1999 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP. GABRIEL J MURACA
K991817 05/27/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP. GABRIEL J MURACA JR.
K991551 05/03/1999 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC JAMES W HAYNES
K991707 05/19/1999 MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 BECKMAN ANGELA BYLAND
K991702 05/19/1999 MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 BECTON DICKINSON VACUTAINER SYSTEMS ANDREA HRONCICCH
K991570 05/05/1999 JOBST READY-TO-WEAR ARM SLEEVES BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K991527 05/03/1999 CHROMOPHARE D500, D530, D650 BERCHTOLD HOLDING GMBH WOLFRAM K HILL
K991840 05/28/1999 FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER BERNARD B. FRESCO BERNARD B FRESCO
K991642 05/13/1999 EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX BERTEC CORP. DOUG MORR
K991726 05/20/1999 BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI BINAX, INC. PAMELA S ANGELL
K991756 05/24/1999 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE BIO-RESEARCH ASSOCIATES, INC. LONNIE WITHAM
K991741 05/21/1999 BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 BIOCHECK, INC. ROBIN J HELLEN
K991604 05/10/1999 EPI-FOAM SILICONE SHEETING BIODERMIS CORP. JEFF S SCHLEUNING
K991585 05/07/1999 BIPOLAR SHOULDER PROSTHESIS BIOMET, INC. FRED MCCLURE
K991763 05/24/1999 LACTOSORB HAND SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K991753 05/24/1999 MAXIM REMOVABLE MOLDED POLY TIBIA BIOMET, INC. FRED MCCLURE
K991807 05/26/1999 TITANIUM LOW PROFILE SCREWS BIOMET, INC. PATRICIA SANDBORN BERES
K991708 05/19/1999 ZIRCONIA 22.22MM CERAMIC MODULAR HEADS BIOMET, INC. DALENE HUFZIGER BINKLEY
K991591 05/07/1999 BIOTHANE PATIENT RESTRAINT BIOPLASTICS CLAIRE BORON
K991549 05/03/1999 EMBOSPHERE MICROSPHERES BIOSPHERE MEDICAL SHEILA HEMEON-HEYER
K991829 05/28/1999 CDTOX A OIA BIOSTAR, INC. ROGER C BRIDEN
K991828 05/28/1999 STREP B OIA BIOSTAR, INC. ROGER C BRIDEN
K991650 05/13/1999 CMV BRITE TURBO KIT BIOTEST DIAGNOSTICS CORP. PATRICIA E BONNESS
K991831 05/28/1999 BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 BOSTON MEDICAL TECHNOLOGIES, INC. DONALD BROKS
K991687 05/17/1999 MODIFICATION TO LINER II: SOFT RELINE LIQUID BOSWORTH CO. MILDRED M GOLDSTEIN
K991750 05/24/1999 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN BRIGHTSWAY HOLDINGS SDN BHD G. BASKARAN
K991752 05/24/1999 BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE BRIGHTSWAY HOLDINGS SDN BHD G. BASKARAN
K991667 05/14/1999 BROADLINE OR TOWELS BROADLINE MEDICAL INDUSTRIES ANNA M RAMZA
K991844 05/28/1999 PRO-GLASS CAD CAM VENTURES RON FISHELL
K991783 05/25/1999 AB-180 XC SYSTEM, MODEL AB-180XC CARDIAC ASSIST, INC. RICHARD G CONFER
K991717 05/20/1999 CARESIDE MG CARESIDE, INC. KENNETH B ASARCH
K991582 05/07/1999 CHIRON DIAGNOSTICS ACS: 180 FOLATE CHIRON DIAGNOSTICS CORP. William J Pignato
K991692 05/18/1999 CHIRON DIAGNOSTICS ACS: 180 FT3 CHIRON DIAGNOSTICS CORP. William J Pignato
K991834 05/28/1999 CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 CHOLESTECH CORP. THOMAS E WORTHY
K991578 05/06/1999 SMARTSPOT 2000 CMT MEDICAL TECHNOLOGIES, LTD. YESHAYAHU RAZ
K991734 05/21/1999 MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. DAVID U THOMAS
K991635 05/12/1999 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. DAVID U THOMAS
K991529 05/03/1999 CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 CONWAY STUART MEDICAL, INC. DAVID A TUCKER
K991811 05/27/1999 CORDIS MAXI DS PTA BALLOON CATHETER CORDIS CORP. ARIEL MACTAVISH
K991674 05/17/1999 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS CORDIS CORP. CHARLES J RYAN
K991673 05/17/1999 CORDIS TEMPO ANGIOGRAPHY CATHETER CORDIS CORP. ARIEL MACTAVISH
K991646 05/13/1999 AGILITY STEERABLE GUIDEWIRE CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K991531 05/03/1999 CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 CORDIS WEBSTER, INC. MARY ADAMS
K991787 05/25/1999 N LATEX IGE MONO REAGENT DADE BEHRING, INC. REBECCA S AYASH
K991705 05/19/1999 N PROTEIN STANDARD UY DADE BEHRING, INC. REBECCA S AYASH
K991704 05/19/1999 N/T PROTEIN CONTROL LC DADE BEHRING, INC. REBECCA S AYASH
K991528 05/03/1999 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR DANEK MEDICAL, INC. RICHARD W TREHARNE
K991637 05/12/1999 BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 DAVOL, INC., SUB. C.R. BARD, INC. RINI GEORGEKUTTY
K991799 05/26/1999 DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO DAVOL, INC., SUB. C.R. BARD, INC. LUCINDA L FOX
K991649 05/13/1999 DEPUY ROCKWOOD CLAVICLE PIN DEPUY, INC. SALLY FOUST
K991608 05/10/1999 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING DERMAPHYLYX, INC. ANDREW M REED
K991609 05/10/1999 DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING DERMAPHYLYX, INC. ANDREW M REED
K991525 05/03/1999 DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF DEROYAL INDUSTRIES, INC. LOIS MARSH
K991814 05/27/1999 MULTACHOICE INSTRUMENTS DEXIDE, INC. JOHN CORZINE
K991561 05/04/1999 ROADRUNNER, PEP THERAPY DEVICE DHD HEALTHCARE CORP. LARRY WEINSTEIN
K991797 05/26/1999 IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K991796 05/26/1999 IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K991795 05/26/1999 IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K991660 05/14/1999 COPALIS MULTIPLEX EBV ANTIBODY ASSAY DIASORIN, INC. JUDITH J SMITH
K991737 05/21/1999 LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR DIDECO S.P.A. BARRY SALL
K991714 05/20/1999 DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K991822 05/27/1999 ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH DR. IHDE DENTAL AG SWITZERLAND MOURAD BARAKET
K991694 05/18/1999 DYNAREX DRAIN SPONGE DYNAREX CORP. JOHN G MOULDEN
K991695 05/18/1999 DYNAREX NON-WOVEN SPONGE DYNAREX CORP. JOHN G MOULDEN
K991721 05/20/1999 EBI OMEGA 21 SYSTEM EBI ELECTRO BIOLOGY JONAS WILF
K991789 05/25/1999 ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS ELAN HOLDINGS, INC. WYNN STOCKING
K991636 05/12/1999 ELEKTA STEREOTACTIC GUIDE ELEKTA INSTRUMENT AB CAROL PATTERSON
K991603 05/10/1999 GRIT BLASTED HUMERAL STEM ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K991790 05/26/1999 ULTIMAX ANKLE FUSION ROD SYSTEM ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K991794 05/26/1999 ENDOSCOPIC SPINAL ACCESS SYSTEM ENDIUS, INC. SUSAN FINNERAN
K991601 05/10/1999 DUAL LUMEN CATHETER, MODEL DL-35-90 ENDOLOGIX, INC. KAREN U SALINAS
K991628 05/11/1999 MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA ESC MEDICAL SYSTEMS, INC. ZVI LADIN
K991729 05/20/1999 FERRIS POLYOSTOMY STERILE WOUND DRESSING FERRIS MFG. CORP. THEODORE THORSEN
K991522 05/03/1999 MICROTARGETING ELECTRODE FHC, INC. FREDERICK HAER
K991560 05/04/1999 NASO-LARYNGO-PHARYNGOSCOPE FIBER IMAGING TECHNOLOGIES, INC. JOSEPH RESS
K991632 05/12/1999 FOTONA NOVALIS ER: YAG LASER SYSTEM FOTONA D.D. MOJCA VALIJAVEC
K991634 05/12/1999 FOTONA NOVALIS R RUBY LASER SYSTEM FOTONA D.D. MOJCA VALIJAVEC
K991520 05/03/1999 FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K991757 05/24/1999 NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE FURLONG INDUSTRIES PETE FURLONG
K991780 05/25/1999 FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C G.T. LABORATORIES, INC. JOHN M SZABOCSIK
K991781 05/25/1999 FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS G.T. LABORATORIES, INC. JOHN M SZABOCSIK
K991774 05/25/1999 ACRON MC MODIFICATION GC AMERICA, INC. TERRY L JORITZ
K991841 05/28/1999 HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS F.I. HAIFA DAN LAOR
K991629 05/11/1999 GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C GE MEDICAL SYSTEMS, INC. LARRY KROGER
K991716 05/20/1999 HISPEED NX/I CT SCANNER SYSTEM GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K991842 05/28/1999 SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING GE VINGMED ULTRASOUND PAUL FREDRIKSEN
K991611 05/10/1999 GE LOGIQ 500 GENERAL ELECTRIC CO. ALLEN SCHUH
K991739 05/21/1999 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN MARIA VITUG FOUTS
K991735 05/21/1999 MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K991786 05/25/1999 MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LAURA L MCCOMIS
K991554 05/03/1999 GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) GLOVCO (M) SDN. BHD. TAN PENG HOCK
K991843 05/28/1999 GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE GREINER MEDITECH, INC. DOUG HARRIS
K991631 05/11/1999 FASTRAY LC HARRY J. BOSWORTH CO. MILDRED J BOSWORTH
K991616 05/10/1999 CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) HARTALEGA SDN BHD KUAN KAM HON
K991587 05/07/1999 BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS HELIX MEDICAL, INC. CYNTHIA ANDERSON
K991563 05/05/1999 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C HENKE SASS WOLF OF AMERICA, INC. ELLEN HENKE
K991773 05/25/1999 HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P HEWLETT-PACKARD GMBH EGON PFEIL
K991535 05/03/1999 CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS HITACHI MEDICAL CORP. OF AMERICA GARY W ENOS
K991543 05/03/1999 INTRAOP CATHETER I-FLOW CORP. STANLEY E FRY
K991526 05/03/1999 ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 IMAGYN MEDICAL TECHNOLOGIES, INC. CHERYL BLAKE
K991723 05/20/1999 TRANSFX MULTI PIN CLAMP IMMEDICA, INC. ROY BOGERT
K991545 05/03/1999 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI GUENTER GINSBERG
K991792 05/26/1999 CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE INFLUENCE, INC. JONATHAN S KAHAN
K991657 05/13/1999 QUANTA LITE ANA ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K991725 05/20/1999 SIDESTREAM NEBULIZER INSPIRED MEDICAL PRODUCTS LTD. PAUL E DRYDEN
K991785 05/25/1999 MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR INSTRUMENTATION INDUSTRIES, INC. TRICIA WOOD
K991572 05/05/1999 ISOLUX SURGICAL HEADLIGHT ISOLUX AMERICA STUART L MCGHEE
K991564 05/05/1999 JELTEMP J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K991688 05/17/1999 WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S JAWON MEDICAL CO., LTD. ROBERT D WAXHAM
K991592 05/07/1999 KSEA DE LA PLAZA BLEPHAROPLASTY SET KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K991738 05/21/1999 DIGITAL VIDEO RECORDING SYSTEM KAY ELEMETRICS CORP. WILLIAM D HARBESON
K991625 05/11/1999 KOMET XK-95 PERFORATOR MOTOR (MI-102) KOMET MEDICAL COURTNEY S PARADICE
K991749 05/24/1999 LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE LAGLOVE (M) SDN. BHD. G. BASKARAN
K991748 05/24/1999 LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G LAGLOVE (M) SDN. BHD. G. BASKARAN
K993096 05/28/1999 PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR LIFESTREAM TECHNOLOGIES, INC. JACKSON B CONNOLLY
K991644 05/13/1999 MICROGAS 7650 TRANSCUTANEOUS MONITOR LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K991715 05/20/1999 BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE LINVATEC CORP. LAURA SENEFF
K991830 05/28/1999 CAPSULAR SHRINKAGE ELECTRODE LINVATEC CORP. LAURA SENEFF
K991677 05/17/1999 REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE) LONDON INTERNATIONAL GROUP, INC. BRADLEY L PUGH
K991754 05/24/1999 GO GLUCOSE MONITORING SYSTEM LXN CORP. NEDA RASHTI
K991640 05/12/1999 HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES M.R.G. INDUSTRIES BERHAD LIM CHONG
K991759 05/24/1999 MAERSK MEDICAL CONTOUR INFUSION SET MAERSK MEDICAL A/S DON SELVEY
K991819 05/27/1999 MAGNATEK 30 MAGNA ADVANCED TECHNOLOGIES, INC. ANNIE VELEZ
K991577 05/06/1999 NIC TONE ACRYLIC RESINS MANUFACTURERA DENTAL CONTINENTAL GARY MOCNIK
K991615 05/10/1999 POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE MAXXIM MEDICAL JOYCE MOODY
K991659 05/14/1999 UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES MEDART CORP. MARILYN M CHOU
K991685 05/17/1999 HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR MEDIC-AID LTD. PAUL E DRYDEN
K991724 05/20/1999 QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 MEDICAL ADVANCES, INC. THOMAS E TYNES
K991719 05/20/1999 EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS MEDIMEX HOLFELD GMBH & CO. DONALD F GRABARZ
K991559 05/04/1999 MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K991755 05/24/1999 MEDLINE TENDER WET WOUND DRESSING MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K991557 05/04/1999 MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC. JAN E DOBSCHA
K991775 05/25/1999 MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS MENNEN MEDICAL, INC. KENNETH RAICHMAN
K991619 05/11/1999 FOUNTAIN INFUSION SYSTEM MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K991532 05/03/1999 DRX QT. HCG METRIKA, INC. YA-CHEN HSU
K991670 05/17/1999 SILVERSTEIN MICROWICK MICROMEDICS, INC. CHARLES GROTE
K991539 05/03/1999 EXCELL 22 MWI, INC. GREGORY A WITHERSPOON
K991656 05/13/1999 AED ARTHROSCOPE NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE M BUTLER
K991823 05/28/1999 N-395 PULSE OXIMETER, MODEL N-395 NELLCOR PURITAN BENNETT, INC. DAVID A. C. GREEN
K991769 05/24/1999 CUTANEOUS (BAR) ELECTRODE NEURO SUPPLIES, INC. RONALD LUICH
K991772 05/24/1999 CUTANEOUS (DISC) ELECTRODE NEURO SUPPLIES, INC. RONALD LUICH
K991770 05/24/1999 CUTANEOUS (GROUND) ELECTRODE NEURO SUPPLIES, INC. RONALD LUICH
K991771 05/24/1999 DIGITAL RING ELECTRDE NEURO SUPPLIES, INC. RONALD LUICH
K991566 05/05/1999 SOLUSTAPLE NEWDEAL S.A. NORMAN F ESTRIN
K991821 05/27/1999 NITRILE EXAMINATION GLOVE, POWDERED, BLUE NING BO YUJIANG RUBBER & PLASTIC CO. JANNA P TUCKER
K991623 05/11/1999 NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA NIPRO MEDICAL CORP. KAELYN HADLEY
K991727 05/20/1999 STAT PROFILE M7 ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K991668 05/14/1999 COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) NOVARTIS NUTRITION CORP. ROBERT J LANG
K991548 05/03/1999 HAL SCOPE HOLDER SYSTEM NOVED MEDICAL MIKE GRIFFIN
K991701 05/19/1999 MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K991672 05/17/1999 OLYMPUS NA-10J-KB ASPIRATION NEEDLE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K991846 05/28/1999 PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE OMNIGRACE LTD. K.C. CHOONG
K991845 05/28/1999 PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. OMNIGRACE LTD. K.C. CHOONG
K991593 05/07/1999 ORIBRUSH - STANDARD - B002 ORIFICE MEDICAL AB PATRIK NILSSON
K991595 05/07/1999 ORIBRUSH - WITH PROTECTIVE TIP - B001 ORIFICE MEDICAL AB PATRIC NILSSON
K991800 05/26/1999 HEMOCHEK URINE COLLECTION KIT OSBORN GROUP, INC. GILBERT P BOURK III
K991586 05/07/1999 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) OSTEOTECH, INC. CHRISTOPHER TALBOT
K991643 05/13/1999 IDS4 V3.2 IMAGE DISPLAY SYSTEM OTECH, INC. HERMAN OOSTERWIJK
K991590 05/07/1999 C-LEG (3C100) OTTO BOCK ORTHOPEDIC INDUSTRY, INC. JOHN HENDRICKSON
K991815 05/27/1999 EXPLORER 3D OUR SCIENTIFIC INTL., INC. MARIO CABALLERO
K991732 05/21/1999 CENTRAFIX EXTERNAL FIXATOR OWANDAR MEDICAL LTD JOHN RADWELL
K991562 05/04/1999 PASCAL MEDICAL AB MENIETT 20 PASCAL MEDICAL AB JEFFREY R SIDEMAN
K991533 05/03/1999 MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION PERIPHERAL AVE SUSAN WALTON
K991658 05/14/1999 PERMOBIL POWERED WHEELCHAIR 1280 PERMOBIL A.B. BENGT PERSSON
K991620 05/11/1999 VISINE FOR CONTACTS PFIZER, INC. JOHN TOMASZEWSKI
K991641 05/12/1999 AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 PHAMATECH CARL A MONGIOVI
K991824 05/27/1999 AT HOME DRUG TEST, MODEL 9171 PHAMATECH CARL A MONGIOVI
K991765 05/24/1999 SYNERGY SHOULDER COIL PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K991568 05/05/1999 MR SPECTROSCOPY PACKAGE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K991826 05/28/1999 PLANMED SOPHIE AND SOPHIE CLASSIC PLANMED OY BOB PIENKOWSKI
K991575 05/06/1999 PRIMUS STEAM STERILIZERS PRIMUS STERILIZER CO., INC. JEFF REED
K991751 05/24/1999 STATUS CUP ACCUSIGN CUP PRINCETON BIOMEDITECH CORP. JEMO KANG
K991618 05/11/1999 BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR PROPPER MFG. CO., INC. JOHN D DYCKMAN
K991633 05/12/1999 QUICKVUE INFLUENZA A/B TEST QUIDEL CORP. MARY DE ARMOND
K991747 05/21/1999 QUICKVUE ONE-STEP H. PYLORI II TEST QUIDEL CORP. Robin Weiner
K991523 05/03/1999 TLC PEDIATRIC FRAME, MODEL TLC-SYS RADIONICS, INC. NANCY C MACDONALD
K991698 05/18/1999 REDI-TEST PCP REDWOOD BIOTECH, INC. JANIS FREESTONE
K991648 05/13/1999 REUSABLE CONTOUR II NASAL MASK RESPIRONICS, INC. DAVID J VANELLA
K991627 05/11/1999 WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 RESPIRONICS, INC. BETSY CORTELLONI
K991827 05/28/1999 GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 RI MOS. S.R.L. ADENA NORA S RIEMER
K991906 05/21/1999 LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K991718 05/20/1999 OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K991598 05/10/1999 COBAS INTEGRA ACETAMINOPHEN ROCHE DIAGNOSTICS CORP. LISA GERARD
K991597 05/10/1999 COBAS INTEGRA AMIKACIN MAB ROCHE DIAGNOSTICS CORP. LISA GERARD
K991653 05/13/1999 INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM RYMED TECHNOLOGIES, INC. AL WEISENBORN
K991788 05/25/1999 SALTER LABS PEP DEVICE SALTER LABS DUANE KAZAL
K991537 05/03/1999 SAMSUNG RAYPAX SYSTEM SAMSUNG SDS CO., LTD HERMAN OOSTERWJICK
K991594 05/07/1999 CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS SANGSTAT MEDICAL CORP. EDA S COOK
K991733 05/21/1999 ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS SCHIAPPARELLI BIOSYSTEMS, INC. STEVEN DALESSIO
K991778 05/25/1999 LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) SELTOM PACIFIC SDN. BHD. S. SEGARAN
K991777 05/25/1999 LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) SELTOM PACIFIC SDN. BHD. S. SEGARAN
K991779 05/25/1999 NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) SELTOM PACIFIC SDN. BHD. S. SEGARAN
K991776 05/25/1999 NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) SELTOM PACIFIC SDN. BHD. S. SEGARAN
K991567 05/05/1999 SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. SHELHIGH, INC. SHLOMO GABBAY
K991743 05/21/1999 ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O SHIELD GLOVES MANUFACTURER (M) SDN BHD E. J. SMITH
K991745 05/21/1999 ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM SHIELD GLOVES MANUFACTURER (M) SDN BHD E. J. SMITH
K991746 05/21/1999 ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR SHIELD GLOVES MANUFACTURER (M) SDN BHD E. J. SMITH
K991744 05/21/1999 SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT SHIELD GLOVES MANUFACTURER (M) SDN BHD E. J. SMITH
K991553 05/03/1999 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION SHIMADZU CORP. MICHAEL FISHBACK
K991652 05/13/1999 HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM SIEMENS CORP. KATHLEEN RUTHERFORD
K991600 05/10/1999 SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION SIEMENS CORP. ALICIA BUSTOS-JUERGENSEN
K991661 05/14/1999 SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K991764 05/24/1999 SOMATOM PROJECT 10-CT SCANNERS SIEMENS MEDICAL SOLUTIONS USA, INC. ALICIA JUERGENSEN
K991599 05/10/1999 CADD ADMINISTRATION SET SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K991624 05/11/1999 POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES SMART GLOVE CORP. SDN BHD FOO KHON PU
K991538 05/03/1999 OPERA CUPFLANGED ACETABULAR COMPONENTS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. JANET JOHNSON GREEN
K991565 05/05/1999 TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S SMV AMERICA PHIL VERNON
K991791 05/25/1999 SOUND VASER SYSTEM SOUND SURGICAL TECHNOLOGIES LLC. WILLIAM W CIMINO
K991613 05/10/1999 SW ULTRASOUND, MODELS 331, 311, 333 STARBENE JUDITH NIZTZSCHMAMN
K991622 05/11/1999 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER STELKAST COMPANY DONALD A STEVENS
K991612 05/10/1999 STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G STERILOGIC WASTE SYSTEMS, INC. CALVIN A ODHNER
K991835 05/28/1999 HANG UPS POWER II STL INTL., INC. ROGER C TEETER
K991706 05/19/1999 VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE STRYKER CORP. NICOLE PETTY
K991696 05/18/1999 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS NICOLE PETTY
K991703 05/19/1999 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS NICOLE PETTY
K991722 05/20/1999 DEVILBISS 5 LITER OXYGEN CONCENTRATOR SUNRISE MEDICAL HHG, INC. GREG CLITES
K991662 05/14/1999 TITANIUM HARTSHILL SYSTEM SURGICRAFT LTD. SIMON FITZER
K991700 05/18/1999 SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO SWEMED LAB INTERNATIONAL AB EDWARD C WILSON
K991808 05/27/1999 OPTIBOND SOLO PLUS 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K991552 05/03/1999 SYNTHES PEDIATRIC ROD SYSTEM SYNTHES (USA) JONATHAN GILBERT
K991647 05/13/1999 TFX MEDICAL INTRODUCER KIT TFX MEDICAL GROUP JULIE A BEAUMONT
K991803 05/26/1999 BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. THE BINDING SITE, LTD. JAY H GELLER
K991802 05/26/1999 BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K991801 05/26/1999 BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K991804 05/26/1999 BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. THE BINDING SITE, LTD. JAY H GELLER
K991758 05/24/1999 MONOJECT INSULIN SYRINGE THE KENDAL CO. FRANK J FUCILE
K991580 05/07/1999 ILM ENDOTRACHEAL TUBE THE LARYNGEAL MASK CO.,LTD. ROBERT L SHERIDAN
K991583 05/07/1999 NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR THE MAGSTIM COMPANY LTD. REZA JALINOUS
K991684 05/17/1999 CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 THERMOGEAR, INC. R. WAYNE FIELDS
K991711 05/19/1999 BISTITE II SC TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K991766 05/24/1999 ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K991710 05/19/1999 SSA-370A/POWERVISION 6000 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K991740 05/21/1999 OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. HSU CHANG
K991810 05/27/1999 MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K991697 05/18/1999 UNI-GOLD H. PYLORI TRINITY BIOTECH, PLC Erika B Ammirati
K991693 05/18/1999 TWO RIVERS POWER LIFT/RECLINE CHAIR TWO RIVERS, LLC. CHRIS WHITAKER
K991720 05/20/1999 KRONUS OPTIQUANT THYROGLOBULIN KIT UNCHANGED A.P. DOERSCCHUK
K991689 05/18/1999 LATEX EXAMINATION GLOVES (POWDER FREE) USG HEALTHGUARD SDN BHD TOH CHEE YEONG
K991690 05/18/1999 LATEX EXAMINATION GLOVES (PRE POWDERED) USG HEALTHGUARD SDN BHD TOH CHEE YEONG
K991602 05/10/1999 EPTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC TIMOTHY J RYAN
K991683 05/17/1999 PTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC TIMOTHY J RYNN
K991669 05/14/1999 PMS 750 FINGERSWITCH WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K991806 05/26/1999 VHS SUPRACONDYLAR PLATE SYSTEM WALTER ABENDSCHEIN, M.D. WALTER ABENDSCHEIN
K991550 05/04/1999 FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS WESLEY JESSEN CORP. JOSEPH FOOS
K991617 05/10/1999 FACE-2-FACE CPR PROTECTION SHIELD WHITELINE PLASTICS, INC. WALLY SIMPSON
K991678 05/17/1999 WHITESIDE BIOMECHANICS SPINAL SYSTEM WHITESIDE BIOMECHANICS, INC. DEBRA MEYER
K991742 05/21/1999 NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O YTY INDUSTRY (MANJUNG) SDN. BHD. E. J. SMITH
K991820 05/27/1999 HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K991610 05/10/1999 ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K991581 05/07/1999 NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO ZIMMER, INC. STEPHEN MCKELVEY
K991556 05/04/1999 ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL MEDICAL CORP. PAUL DIAS


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