FDA 510(k) Applications Received During June, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K012013 06/28/2001 LIFESOURCE MODELS UA-787, UA 787PC, UA-787T A & D ENGINEERING, INC. JERRY WANG
K011929 06/20/2001 HANDPIECE SHEATH-MODEL #A910 AARON MEDICAL, INC. RICHARD KOZLOFF
K011801 06/08/2001 FUTURA TOPCAP NON GAMMA-2 AB ARDENT CLYDE E INGERSOLL
K012014 06/12/2001 MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. EVE A CONNER
K011752 06/06/2001 GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY ACCUFAST, INC. DON LOGAN
K012018 06/28/2001 BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 ACMI CORPORATION FRANK J FUCILE
K011730 06/05/2001 ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K011994 06/26/2001 ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 ACRYMED, INC. BRUCE GIBBINS
K011962 06/22/2001 ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST ADVANTAGE DIAGNOSTICS CORP. JANIS FREESTONE
K012010 06/27/2001 MODIFICATION TO LR 5200 FILM RECORDER AGFA CORP. T.WHIT ATHEY
K011824 06/11/2001 AGILENT M2636B TELEMON B MONITOR (TELEMON B) AGILENT TECHNOLOGIES, INC. DENISE HALEY
K012037 06/29/2001 HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 AIRSEP CORP. CHARLOTTE H HAMILTON
K011721 06/04/2001 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K011814 06/11/2001 AMEDITECH IMMUTEST DRUG SCREEN COC AMEDITECH, INC. JOHN WU
K011813 06/11/2001 AMEDITECH IMMUTEST DRUG SCREEN THC AMEDITECH, INC. JOHN WU
K012159 06/22/2001 RAPID DRUG SCREEN AMERICAN BIO MEDICA CORP. FRAN WHITE
K011706 06/04/2001 FLEXICAST PRIME AMERICAN DENT-ALL, INC. VACHAKAN H KHOIE
K011705 06/04/2001 SUPREMCAST AMERICAN DENT-ALL, INC. VACHAKAN H KHOIE
K011910 06/19/2001 IN-FAST BONE SCREW SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K012029 06/28/2001 REMEDY MODEL 2Z12 APOLLO CORP. ADRIAN SWEEN
K011761 06/06/2001 MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT ARROW INTL., INC. THOMAS D NICKEL
K011808 06/11/2001 ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) ASIA-MED GMBH AND CO KG KEVIN WALLS
K011834 06/12/2001 BIS ENGINE ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K011722 06/04/2001 ATRICURE BIPOLAR COAGULATION SYSTEM ATRICURE, INC. MARK L FRIEDMAN
K011819 06/11/2001 RADIAL HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K011779 06/07/2001 AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM AVID CARE CORP. JONATHAN S KAHAN
K011912 06/19/2001 MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 AXYA MEDICAL, INC. HOWARD L SCHRAYER
K011975 06/25/2001 HORIZON OUTLOOK WITH DOSECOM B. BRAUN MEDICAL, INC. LINDA MORGAN
K011718 06/04/2001 BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT BAUSCH & LOMB, INC. DEBRA KETCHUM
K011796 06/08/2001 RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K011963 06/22/2001 ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY BAYER CORP. KENNETH T EDDS
K011982 06/26/2001 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE BD GREGORY W MORGAN
K011967 06/25/2001 BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE BD GREGORY W MORGAN
K011858 06/14/2001 INTERLINK THREADED LOCK CANNULA BD GREGORY W MORGAN
K011984 06/26/2001 BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET BECTON DICKINSON & CO. M. WENDY BOSSHARDT
K011853 06/13/2001 ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 BIO-RAD DONNA CHAPMAN
K011867 06/14/2001 LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 BIO-RAD DONNA CHAPMAN
K012019 06/28/2001 COLOR BUFFED (CB) DDH FEMORAL STEM BIOMET, INC. DALENE T BINKLEY
K011795 06/08/2001 WORLAND UNICONDYLAR TIBIAL BEARING BIOMET, INC. TRACY J BICKEL
K012000 06/27/2001 1.5MM BONE FIXATION KIT BIONX IMPLANTS, LTD. TUIJA ANNALA
K012001 06/27/2001 SMARTSCREW BIONX IMPLANTS, LTD. TUIJA ANNALA
K011970 06/25/2001 BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K012032 06/29/2001 FIRST SPEP BISCO, INC. KATHY LONG
K011906 06/19/2001 BACK-UP MEIER GUIDEWIRE BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K011965 06/25/2001 IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 BOSTON SCIENTIFIC CORP. ROBERT J MICHALIK
K011889 06/18/2001 ULTRA -THIN SDS BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K011909 06/19/2001 ULTRA-THIN SDS BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K012035 06/29/2001 BRAUN PRECISION SENSOR PRO, MODEL BP 2590 BRAUN GMBH FRED SCHLADOR
K011728 06/04/2001 BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K011797 06/08/2001 BIOZTECT SENSOR AND BIOZTECT CABLE CARDIODYNAMICS INTERNATIONAL CORP. BRAIN PARK
K011988 06/26/2001 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C CARDIOFOCUS, INC. JOSEPH CURTIS
K011861 06/14/2001 BERNOULLI VENTILATOR MANAGEMENT SYSTEM CARDIOPULMONARY CORP. JOHN LAVIOLA
K011877 06/15/2001 FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM CARL ZEISS JENA GMBH JOHNATHAN S KAHAN
K011855 06/13/2001 WAMPOLE HS-CRP ELISA CARTER-WALLACE, INC. MAUREEN GARNER
K011840 06/12/2001 CERVILENZ UTERINE MEASURING SOUND CERVILENZ INC JUDY F GORDON
K011888 06/18/2001 PRESSURE ACTIVATED CHECK VALVE CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K011848 06/13/2001 CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE CIRCON VIDEO JERRY CROUTHERS
K011876 06/15/2001 DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 CIRCON VIDEO JOHN DELUCIA
K011849 06/13/2001 MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS CIRCON VIDEO WAYNE B STERNER
K011835 06/12/2001 COBE REVOLUTION COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K011880 06/15/2001 COMPEX SPORT COMPEX S.A. ANSIS M HELMANIS
K011893 06/18/2001 COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES CONTACT COLOR SRL MARIA E DONAWA
K011812 06/11/2001 SPECTRUM VENTRICULAR CATHETER COOK, INC. APRIL LAVENDER
K011828 06/12/2001 CYNOSURE ACCLAIM DERMATOLOGY LASER CYNOSURE, INC. GEORGE CHO
K011852 06/12/2001 DIMENSION HAIC ASSAY, MODEL DF105 DADE BEHRING, INC. CATHY CRAFT
K012005 06/27/2001 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K011999 06/27/2001 MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K011868 06/14/2001 ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS DEBIOTECH S.A. SEAN CURRY
K011958 06/22/2001 CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT DENKA SEIKEN'S SEIYA SATO
K011762 06/07/2001 HI-WAVE; POUR-PLUS DENPLUS, INC. SHUOJIA DONG
K011862 06/14/2001 DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT DENVER BIOMEDICAL, INC. BONNIE B VIVIAN
K011831 06/12/2001 MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS DENVER BIOMEDICAL, INC. BONNIE VIVIAN
K011810 06/11/2001 ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING DEPUY, INC. JANET G JOHNSON
K011729 06/04/2001 SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 DNI NEVADA, INC. KRISTINE BOGGS
K011736 06/05/2001 DRG QUICKMIX DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIES
K012003 06/27/2001 DRG REACTION CHAMBER/SAFETY TIP DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K011773 06/07/2001 DORNIER LITHOTRIPTER 140("DOLI 140") DORNIER SUZANNE COURTNEY
K011873 06/15/2001 DORNIER LITHOTRIPTER S("DOLI S") & DORNIER LITHOTRIPTER S-XP ("DOLI S-XP") DORNIER SUZANNEW COURTNEY
K011839 06/12/2001 DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C DOXA CERTEX AB JONATHAN S KAHAN
K011898 06/18/2001 E-STETH ELECTRONIC STETHOSCOPE E-MED INNOVATIONS, INC. HUGH E HACKNEY
K011697 06/01/2001 EBI XFIX ACCESS PELVIC FIXATOR EBI, L.P. FREDERIC TESTA
K012024 06/28/2001 EBI XFIX DFS SYSTEM EBI, L.P. JON CAPAROTTA
K011711 06/04/2001 MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM EBI, L.P. PATRICIA FLOOD
K011856 06/13/2001 RADIOGRAPHIC MARKERS ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K011830 06/12/2001 TRI-FIX SPINAL FIXATION SYSTEM ENDIUS, INC. SUSAN FINNERAN
K012031 06/28/2001 MODIFICATION TO THERMAL ANGEL ESTILL MEDICAL TECHNOLOGIES, INC. DANIEL T KISTNER
K011976 06/25/2001 OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) EXACTECH, INC. GARY J MILLER
K011794 06/08/2001 XLTEK LED GOGGLES, MODEL LED-01 EXCEL TECH. LTD. SONJA MARKEZ
K011757 06/06/2001 EXEL COMFORTPOINT INSULIN PEN NEEDLE EXELINT INTL. CO. ARMAND HAMID
K011754 06/06/2001 EXEL SECURETOUCH PTP SYRINGE EXELINT INTL. CO. ARMAND HAMID
K011874 06/15/2001 FADASIS MEDICAL FM-1 NO BLENDER FADASIS MEDICAL, INC. RAYMOND RIDDLE
K011983 06/26/2001 INSIGHT GENESIS FASSTECH LEE BRODY
K011964 06/25/2001 INSIGHT MILLENNIUM PLUS FASSTECH LEE BRODY
K011992 06/26/2001 FHC MICROTARGETING DRIVE SYSTEM FHC, INC. FREDERICK HAER
K011775 06/07/2001 MICRO TARGETING DRIVE SYSTEM FHC, INC. FREDERICK HAER
K011939 06/21/2001 FOTONA DUALIS, FOTONA DUALIS PLUS FOTONA D.D. MOJCA VALJAVEC
K011950 06/21/2001 SEEDNET, MODEL FP6T5, FP5T5, FP5T3 GALIL MEDICAL LTD. JONATHAN S KAHAN
K011917 06/20/2001 ADVANCED HIP ASSESSMENT SOFTWARE GE LUNAR CORP. JAMES P RASKOB
K011843 06/12/2001 GENZYME DIRECT-AMYLASE TEST REAGENT GENZYME CORP. BARBARA PIZZA
DEN010002 06/11/2001 GIVEN DIAGNOSTIC IMAGING SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K011699 06/01/2001 VACUETTE EVACUATED BLOOD COLLECTION TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA JUDI SMITH
K012043 06/29/2001 VACUETTE EDTA K2 GEL TUBES GREINER VACUETTE NORTH AMERICA, INC. JUDI SMITH
K011786 06/08/2001 VACUETTE SAFETY BLOOD COLLECTION SET GREINER VACUETTE NORTH AMERICA, INC. JUDI SMITH
K011881 06/18/2001 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. SABA MODJARRAD
K012002 06/27/2001 VIKING OPTIMA GUIDING CATHETER GUIDANT CORP. STACEY SIMON
K012012 06/28/2001 ECG HOME H&C MEDICAL DEVICES SPA ATTILIO CASTELLI
K011741 06/05/2001 CRIT-LINE MONITOR III TQA (CLM TQA) HEMAMETRICS MATTHEW L HAYNIE
K012045 06/29/2001 HIGHGATE CURVED ROD SYSTEM HIGHGATE ORTHOPAEDICS KAREN E WARDEN
K011979 06/25/2001 ALLERSHARP ALLERGY SKIN TESTER HMB MEDICAL CONCEPTS, LTD. GAVIN MCLACHLAN
K011916 06/20/2001 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES HORIZON MEDICAL PRODUCTS, INC. PENNY M NORTHCUTT
K012027 06/28/2001 MODIFICATION TO XIA SPINE SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K011948 06/21/2001 HOFFMAN II HYBRID RING CLAMP HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K012026 06/28/2001 TRIDENT ALL POLY CUP HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K012008 06/27/2001 STS RANGE , MODELS STS20,STS30,STS40 HUNTLEIGH HEALTHCARE, INC. AUDREY WITKO
K011866 06/14/2001 OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES HYPERBARIC TECHNOLOGIES, INC. DAVE HEANEY
K011971 06/25/2001 NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K012047 06/29/2001 3I CALCIUM SULFATE BONE CEMENT IMPLANT INNOVATIONS, INC. MARY L VERSTYNEN
K011904 06/19/2001 NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) IMPLEX CORP. ROBERT A POGGIE
K011914 06/19/2001 HYDRO2, HS-75 INNOVISION, INC. DON M WOODFORD
K011698 06/01/2001 STRAUMANN GBR SYSTEM INSTITUT STRAUMANN AG LINDA JALBERT
K011972 06/25/2001 DIRECT BILIRUBIN REAGENT INTERSECT SYSTEMS, INC. MARK E LEGAZ
K011986 06/26/2001 SAFE-STEER GUIDE WIRE SYSTEM INTRALUMINAL THERAPEUTICS, INC. PAMELA L MISAJON
K011938 06/21/2001 OIL FOR EMBRYO CULTURE IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K011900 06/18/2001 GLUCOSE (HEXOKINASE) JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K012038 06/29/2001 JAS URIC ACID LIQUID REAGENT JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K011748 06/06/2001 FIRST FILL R.C.S. JENERIC/PENTRON, INC. ANNMARIE TENERO
K011780 06/07/2001 K-ASSAY C1-INA KAMIYA BIOMEDICAL CO. COLIN GETTY
K011841 06/12/2001 KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR KARL STORZ ENDOSCOPY JAMES A LEE
K011700 06/01/2001 MODULITH SLK LITHOTRIPTER KARL STORZ ENDOSCOPY JENNIFER S PORTUGAL
K011793 06/08/2001 KSEA FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K011943 06/21/2001 IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR KENSEY NASH CORP. JULIE N BRODERICK
K011908 06/19/2001 OPTIBOND SOLO PLUS 3 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K011725 06/04/2001 OLYMPUS SUCTION PUMP, MODEL KV-5 KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. ROGER GRAY
K011860 06/14/2001 KEYST0NE MEDICAL PICC CATHETER KEYSTONE MEDICAL ALAN P SCHWARTZ
K011713 06/04/2001 SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE KIMBERLY-CLARK CORP. MARCIA JOHNSON
K011859 06/14/2001 KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH
K011968 06/25/2001 STREERABLE PTCA GUIDEWIRE LAKE REGION MFG., INC. JEFF PUMPER
K011960 06/22/2001 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "POCKETPRO OR POCKETPRO S4") LARES RESEARCH, INC. THOMAS H LOUISELL
K011792 06/08/2001 NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES LATEXX PARTNERS BHD. CHRISTINA SMITH
K011791 06/08/2001 POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR LATEXX PARTNERS BHD. CHRISTINA SMITH
K011987 06/26/2001 MODIFIED M-IV MAMMOGRAPHY SYSTEM LORAD, A HOLOGIC CO. ROAIDA RIZKALLAH
K011703 06/01/2001 LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES LUMENIS LISA MCGRATH
K011715 06/04/2001 MACROPORE IB RESORBABLE PLUG MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K012025 06/28/2001 MACROPORE SURGIWRAP (TS) MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K011746 06/06/2001 MB 11 MAICO DIAGNOSTIC GMBH DANIEL E EGGAN
K011785 06/08/2001 NOVEL PRINT CYAN ALGINATES MANUFACTURERA DENTAL CONTINENTAL GARY S MOCNIK
K012009 06/27/2001 MX8000 IDT CT SYSTEM MARCONI MEDICAL SYSTEMS, INC. ROBERT L TUROCY
K011851 06/13/2001 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K011845 06/12/2001 MILLCOMP MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K011905 06/19/2001 SNIPER ELITE MODEL-OR-E3872XX SERIES MAXXIM MEDICAL GAIL DOHERTY
K011740 06/05/2001 CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) MEDDEV CORP. SUZANNA BRICK
K011731 06/05/2001 TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 MEDICAL ANALYSIS SYSTEMS, INC. DARWIN RICHARDSON
K012006 06/27/2001 MEDICAL DEPOT POWER NEB 1 MEDICAL DEPOT, INC. ART WARD
K011790 06/08/2001 MICROCRUISER PLUS INTRODUCER SET MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K012030 06/28/2001 PORTABLE INTENSIVE CARE UNIT MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K011991 06/26/2001 MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR MEDRAD, INC. LORRAINE R FREDES
K011817 06/11/2001 BRIDGE FX MEDTRONIC AVE, INC. JOHN RIOLO
K011998 06/27/2001 METRONIC SOFAMOR DANEK CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K011864 06/14/2001 TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B MEDTRONIC VASCULAR MARIE HOLM
K011784 06/08/2001 MODIFICATION TO ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. EREZ NIMROD
K011811 06/11/2001 MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE MERIT MEDICAL SYSTEMS, INC. DAN REIGLE
K011844 06/12/2001 MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS MERITS HEALTH PRODUCTS., INC. LEE LEICHTER
K011751 06/06/2001 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
K011753 06/06/2001 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
K011707 06/04/2001 TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 MERITS MEDICAL INDUSTRIES CO., LTD. WINSTON ANDERSON
K011955 06/22/2001 MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K011981 06/25/2001 MHS 5000 MICRO HEALTH SYSTEMS INC. ROBERT BARNES
K011937 06/21/2001 TRULINE INFUSION CATHETERS MICRO THERAPEUTICS, INC. EBEN GORDON
K011952 06/21/2001 DRUGS OF ABUSE MULTI-TEST STRIP MICRODIAGNOSTICS, INC. JUNE SHOZI
K011826 06/11/2001 EPS320 CARDIAC STIMULATOR MICROPACE PTY. LTD. MICHAEL CEJNAR
K011726 06/04/2001 MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER MILLENIUM BIOLOGIX, INC. ROBERT SCHIFF
K011833 06/12/2001 MB 103 MILLENNIUM BLADES MILLENNIUM BIOMEDICAL, INC. JERRY KAENI
K012028 06/28/2001 ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 MISONIX, INC. ALBERT F CLANCY
K011734 06/05/2001 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX MOGUL ENTERPRISES JAMIL MOGUL
K011816 06/11/2001 MINI MULTILEAF COLLIMATOR, MODEL KMI MRC SYSTEMS GMBH JORG STEIN
K011926 06/20/2001 ELEC-MATE E NAKANISHI, INC. HIROJI SEKIGUCHI
K011820 06/11/2001 DENTORIUM CONVERTIBLE ACRYLIC NATS CORP. RICHARD C LANZILLOTTO
K011946 06/21/2001 THE SPIN SNAP-OFF SCREW NEW DEAL, S.A. NORMAN F ESTRIN
K011821 06/11/2001 MODIFICATION TO THE I.C.O.S SCREW NEWDEAL S.A. NORMAN F ESTRIN
K011875 06/15/2001 MODIFICATION TO THE TAC' PIN NEWDEAL S.A. MORGANE GRENIER
K011716 06/04/2001 THE UNI-CLIP STAPLE NEWDEAL S.A. NORMAN F ESTRIN
K011823 06/11/2001 BIOREHAB SYSTEM NICOLET BIOMEDICAL, INC. GARY J SYRING
K011818 06/11/2001 STERILE EMG ELECTRODES NICOLET BIOMEDICAL, INC. GARY SYRING
K011918 06/20/2001 NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K011949 06/21/2001 ELK LASER IMAGER, MODEL EL-DRY 4000 NISHIMOTO SANGYO CO., LTD. GARY J ALLSEBROOK
K012020 06/28/2001 RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC NON-INVASIVE MONITORING SYSTEMS, INC. ALLAN F BRACK
K011704 06/01/2001 NPAC EAR THERMOMETER MODEL TD 402 NORM PACIFIC AUTOMATION CORP. CHI-CHU WU CHEN
K011928 06/20/2001 HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K011720 06/04/2001 OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K011886 06/15/2001 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K011769 06/07/2001 OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND OPUSDENT LTD. SHOSHANA FRIEDMAN
K011887 06/18/2001 AVALON CUP SYSTEM ORTHOPEDIC SOURCE INC. STEVEN L MANDELL
K011827 06/12/2001 ORTELIUS 800 ORTHOSCAN LTD. SHOSHANA FRIEDMAN
K011807 06/11/2001 SCS CLARIS SPINAL SCREWS, TYPES V,G,E ORTHOTEC,LLC KAREN E WARDEN
K011879 06/15/2001 3A DENTAL IMPLANT SYSTEM OSSECO BIOSOURCE, LTD MICHELE H VOVOLKA
K011774 06/07/2001 R120 MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K011951 06/21/2001 EZ SYRINGE OWEN MUMFORD, LTD. ROBERT SHAW
K011710 06/04/2001 OXOID PBP2 1 LATEX AGGLUTINATION TEST OXOID, LTD. A. HOLLINGSWORTH
K011980 06/25/2001 ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 PACE MEDICAL ROBERT C MACE
K011997 06/27/2001 MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX PAJUNK GMBH MARTIN HAUGER
K011747 06/05/2001 PALOMAR LC 100 DIODE LASER PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K011891 06/18/2001 PANAG PANAG INTERNATIONAL PETER KALABAKAS
K011899 06/18/2001 PF 5050 PRESSURE UNIT, MODEL PF 5050 PERIMED AB BJORN BAKKEN
K011783 06/07/2001 MULTI-SNARE SET PFM PRODUKTE FUR DIE MEDIZIN AG SALVADORE F PALOMARES
K011723 06/04/2001 ANTI-SNORING DEVICE OR "ASD" PI MEDICAL LINDA S ALEXANDER
K011836 06/12/2001 MPF ACETABULAR CUP PLUS ORTHOPEDICS HARTMUT LOCH
K011719 06/04/2001 PLUS CANCELLOUS BONE SCREWS PLUS ORTHOPEDICS HARTMUT LOCH, RAC
K011945 06/21/2001 RIGID GAS PERMEABLE CONTACT LENS SOLUTION POLYMER TECHNOLOGY CORP. DEBRA L.B. KETCHUM
K013068 06/28/2001 BIOSCANNER 2000 POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K011993 06/26/2001 QUANTUM BLAST PRIDE MOBILITY PRODUCTS CORP. GENE R KULON
K011789 06/08/2001 PROCEDURE MASKS: PM4-301 AND PM4-304 PRIMELINE MEDICAL PRODUCTS, INC. KATHERINE CO
K011996 06/27/2001 TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS PROCTER & GAMBLE CO. MARK M ANDERSON
K011933 06/20/2001 GLYCOSAL II HBA 1C TEST PROVALIS DIAGNOSTICS LTD. THOMAS M TSAKERIS
K011712 06/04/2001 LATEX EXAMINATION GLOVES- POWDER FREE, BLUE PT. SHAMROCK MANUFACTURING CORP. EMMY TJOENG
K011895 06/18/2001 POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH PWA INDUSTRIES SDN. BHD. K. KARUNAKARAN
K011995 06/26/2001 POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) QUALITY LATEX PRODUCTS MALAYSIA SDN BHD SHARENE WAN
K011759 06/06/2001 RADIUS NEXT GENERATION GUIDEWIRE RADIUS MEDICAL TECHNOLOGIES, INC. MAUREEN FINLAYSON
K011771 06/06/2001 RANDOX THEOPHYLLINE RANDOX LABORATORIES, LTD. P ARMSTRONG
K012224 06/16/2001 SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW RANFAC CORP. GEORGE J HATTUB
K012044 06/29/2001 BI-PHASIC INFILTRATOR RELIANCE MEDICAL CORP. ROBERT W NICKS
K012042 06/29/2001 KINETIC CANNULA RELIANCE MEDICAL CORP. ROBERT W NICKS
K011714 06/04/2001 BIPAP PRO BI-LEVEL SYSTEM RESPIRONICS, INC. DAVID J VANELLA
K012040 06/29/2001 RAMP MYOGLOBIN ASSAY RESPONSE BIOMEDICAL CORP. WILLIAM J RADVAK
K012007 06/27/2001 RHS HELMET RESTORATIVE HEALTH SVS, INC. DAVID J BLOCH
K011837 06/12/2001 LIFECARD CF 7 DAY REYNOLDS MEDICAL LTD. GEORGE MYERS
K011911 06/19/2001 SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K011822 06/11/2001 PIT AND FISSURE CHEMICAL CURING SEALANT RITE-DENT MANUFACTURING CORP. CESAR E VELIZ
K011846 06/12/2001 BIOTECH POWERED WHEELCHAIR, C650PW ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY JEN KE-MIN
K011738 06/05/2001 ACCU-CHEK ACTIVE SYSTEM ROCHE DIAGNOSTICS CORP. MIKE FLIS
K011935 06/21/2001 REJUVENIQUE MODEL #RJV10 SALTON, INC. GEORGIA C RAVITZ
K011763 06/07/2001 OMNIDOS SCANDITRONIX MEDICAL AB ALF OHMAN
K012033 06/29/2001 MULTIFUNCTION ENDOSCOPIC INSTRUMENT SEEDLING ENTERPRISES. LLC. DEBBIE IAMPIETRO
K011924 06/20/2001 POWDERED BLUE NITRILE EXAMINATION GLOVES SELTOM PACIFIC SDN. BHD. S SEGARAN
K011922 06/20/2001 POWDERED LATEX EXAMINATION GLOVES SELTOM PACIFIC SDN. BHD. S. SEGARAN
K012023 06/28/2001 ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE SENORX, INC. AMY BOUCLY
K012004 06/27/2001 EASY GUIDE ELECTROSURGICAL ACCESS DEVICE SENORX, INC. AMY BOUCLY
K011974 06/25/2001 SENSAID SENSIDYNE, INC. GEORGE MASON
K012034 06/29/2001 MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT SENSORMEDICS CORP. ALEX STENZLER
K011961 06/22/2001 POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 SHEN WEI (USA), INC. BELLE L CHOU
K011883 06/18/2001 POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011884 06/18/2001 POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011882 06/18/2001 SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K011885 06/18/2001 SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. JAMES CHU
K012016 06/28/2001 INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K011825 06/11/2001 RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE SIGHTLINE TECHNOLOGIES LTD. SIMCHA EDELL
K011907 06/18/2001 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM SIMS LEVEL 1, INC. GABRIEL J MURACA, JR.
K011925 06/20/2001 HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO SIMS PORTEX, INC. BRAIN D FARIAS
K011842 06/12/2001 SABRE COMPAC SLE LIMITED FRANK FERGUSON
K011944 06/21/2001 DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 SMITH & NEPHEW, INC. STEVEN JACKSON
K011985 06/26/2001 SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT SMITH & NEPHEW, INC. TIM CRABTREE
K011766 06/07/2001 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 ST. JUDE MEDICAL ANGELA BYLAND
K011788 06/08/2001 EVERSTICK STICK TECH LTD. WILLIAM M TROETEL
K011799 06/08/2001 EVERSTICKNET STICK TECH LTD. WILLIAM M TROETEL
K011838 06/12/2001 CENTRIFUGAL PUMP STOCKERT INSTRUMENTE GMBH ROSINA ROBINSON
K012011 06/28/2001 MODIFICATION TO A620 EEG STOELTING CO. KENNETH L BIRD
K011755 06/06/2001 STRYKER T4 HYTREL (R) TOGAS STRYKER CORP. SUZANNE VELASQUEZ
K011806 06/11/2001 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K011954 06/22/2001 SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE SULZER ORTHOPEDICS, INC. BRUCE WALDON
K011913 06/19/2001 SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES SUN-RAIN SYSTEM CORP. YANG TIEN-HISING
K011765 06/07/2001 SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE SUNMAX ENTERPRISE SHANGHAI CO. LTD. SUSAN D GOLDSTEIN-FALK
K011717 06/04/2001 SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES SUNMAX ENTERPRISE SHANGHAI CO. LTD. SUSAN D GOLDSTEIN-FALK
K011781 06/07/2001 INTERCEPT-URETHRAL MICROCOIL SURGI-VISION, INC. NANCY E TAYLOR
K011901 06/18/2001 FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 SURVIVALINK CORP. JOHN CARLINE
K011798 06/08/2001 CORERESTORE 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K011897 06/18/2001 NORIAN SRS BONE VOID FILLER SYNTHES (USA) ANGELA J SILVESTRI
K011857 06/14/2001 SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM SYNTHES (USA) BONNIE J SMITH
K011969 06/25/2001 SYNTHES CERVIFIX SYSTEM SYNTHES (USA) JONATHAN GILBERT
K011815 06/11/2001 SYNTHES LCP PROXIMAL HUMERUS PLATES SYNTHES (USA) MATTHEW M HULL
K011978 06/25/2001 SYNTHES LCP PROXIMAL TIBIA PLATE SYNTHES (USA) MATTHEW M HULL
K011878 06/15/2001 EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL SYVA CO. SUSAN L COLLINS
K011947 06/21/2001 EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL SYVA CO. SUSAN L COLLINS
K011920 06/20/2001 EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 SYVA CO., DADE BEHRING, INC. SUSAN L COLLINS
K011701 06/01/2001 BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR TAIWAN ARMADA ENTERPRISE CO., LTD. JEN KE-MIN
K012041 06/29/2001 THE HAMMER MODEL H100 TENACORE HOLDINGS, INC. BRAND CASO
K011804 06/11/2001 CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K011941 06/21/2001 EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 THE KENDALL COMPANY MICHAEL SPEARS
K011869 06/14/2001 XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K011768 06/07/2001 THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 THERMO-ELECTRIC CO. LAWRENCE E MADSON
K011727 06/04/2001 TRANSSEPTAL NEEDLE/TROCAR THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K011854 06/13/2001 TOKUYAMA M-BOND TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K011942 06/21/2001 AEQUALIS PRESS-FIT SHOULDER PROSTHESIS TORNIER IRENE GOSSET
K011745 06/06/2001 HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. JUAN C RIVERA
K011744 06/05/2001 HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. JUAN C RIVERA
K011803 06/11/2001 SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K011709 06/04/2001 UNI-GOLD STREP A TEST KIT TRINITY BIOTECH, PLC FIONA CAMPBELL
K011800 06/08/2001 VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K011832 06/12/2001 VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012017 06/28/2001 VARISEED 7.0 VARIAN MEDICAL SYSTEMS LINDA S NASH
K011863 06/14/2001 VCS-A SERIES CLAMP VASCULAR CONTROL SYSTEMS, INC AL MEMMOLO
K011957 06/22/2001 IVENT 201 PORTABLE VENTILATOR VERSAMED LTD. KEN RAICHMAN
K011702 06/01/2001 VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX VERTIS NEUROSCIENCE, INC. LORI GLASTETTER
K011787 06/08/2001 PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE VIDAMED, INC. YI CHEN
K011903 06/18/2001 LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE VIVOMETRICS, INC. KEITH GILROY
K011756 06/06/2001 ADMIRA FLOW VOCO GMBH EVAN DICK
K011708 06/04/2001 MODIFICATION TO WARTNER WART REMOVAL SYSTEM WARTNER MEDICAL PRODUCTS NANCY LUM-WILSON
K011953 06/21/2001 WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K012048 06/29/2001 POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K011865 06/14/2001 ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION ZOLL MEDICAL CORP. PAUL DIAS
K011847 06/13/2001 ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE ZYNERGY CARDIO VASULAR (ZCV), INC. JING ZHANG


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