FDA 510(k) Applications Received During March, 1998

FDA 510(k) Number Submission Date Device Name Applicant Contact
K980824 03/04/1998 A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K981135 03/30/1998 ETEST BENZYLPENICILLIN AB BIODISK ANNE BOLMSTROM
K980877 03/09/1998 ETEST CEFDINIR AB BIODISK ANNE BOLMSTROM
K981137 03/30/1998 ETEST CEFOTAXIME AB BIODISK ANNE BOLMSTROM
K981139 03/30/1998 ETEST CEFTRIAXONE AB BIODISK ANNE BOLMSTROM
K981138 03/30/1998 ETEST CIPROFLOXACIN AB BIODISK ANNE BOLMSTROM
K981136 03/30/1998 ETEST FOSFOMYCIN AB BIODISK ANNE BOLMSTROM
K980773 03/02/1998 ETEST GREPAFLOXACIN AB BIODISK ANNE BOLMSTROM
K981134 03/30/1998 ETEST TETRACYCLINE AB BIODISK ANNE BOLMSTROM
K981060 03/23/1998 ABBOTT AXSYM 3RD GENERATION TSH ASSAY ABBOTT LABORATORIES APRIL VEOUKAS
K981118 03/27/1998 PHOS ABBOTT LABORATORIES MARK LITTLEFIELD
K981131 03/30/1998 PATHFINDER MOBILE C ARM ACOMA MEDICAL IMAGING, INC. JAMES LAMBRECHT
K981113 03/27/1998 PEDIATRIC PRC ACROMED CORP. WILLIAM CHRISTIANSON
K980867 03/06/1998 3D-MSPECT ADAC LABORATORIES DENNIS W HENKELMAN
K980844 03/04/1998 SURGIDEV SILICONE PUNCTUM PLUG ADVANCED VISION SCIENCE KHALID MENTAK
K981196 03/19/1998 MEDITEC LINK AESCULAP-MEDITEC NORTH AMERICA WILLIAM T KELLEY
K980806 03/03/1998 AFFINITY MEDICAL PATIENT CABLE SYSTEM AFFINITY MEDICAL TECHNOLOGIES, LLC. MARY F PHILLIPP
K981054 03/23/1998 BROWNE GA INDICATOR FOR CIDEX PRODUCTS ALBERT BROWNE LTD. CYNTHIA J M NOLTE, PH.D
K981151 03/30/1998 OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 ALCON LABORATORIES RALPH H LARSEN
K981103 03/26/1998 TURBOSONICS LIMITED REUSE ULTRASONIC TIP ALCON LABORATORIES MARTIN A KAUFMAN
K981095 03/26/1998 ALIGN SYSTEM ALIGN TECHNOLOGY CAROL PATTERSON
K980892 03/09/1998 HAKOMED ELECDT / PRO ELEDT SERIES ALIVE, INC. KAI HANSJURGENS
K980958 03/16/1998 HAKOMED ELECDT/VACUPULLS ALIVE, INC. KAI HANSJURGENS
K980775 03/02/1998 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K981116 03/27/1998 SOVEREIGN CATARACT EXTRACTION SYSTEM ALLERGAN, INC. MARCIA S YAROSS, PH,D.
K980788 03/02/1998 ALPHATEC WIRE EXTERNAL FIXATION SYSTEM ALPHATEC MFG., INC. DAN PASTRICK
K980872 03/06/1998 RAPID DRUG SCREEN' 8 PANEL AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K981121 03/27/1998 AMIGO RT AMIGO MOBILITY INTL., INC. ANDREA J LUPO
K980929 03/12/1998 DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES ANSELL PERRY JAMES R CHATTERTON
K980880 03/09/1998 SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) ANSELL PERRY JAMES R CHATTERTON
K980836 03/04/1998 GENIE CUP INTEGRATED SCREENING DEVICE APPLIED TECHNOLOGY VENTURES, L.L.C. RICHARD ROBLIN
K981144 03/30/1998 CLEAN SOURCE I, MODEL CS1000 AQUARIUS TECHNOLOGIES, INC. WILLIAM JEFFERS
K980860 03/05/1998 HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM ATLANTIS DIAGNOSTICS INTL., INC. TERRENCE J SWEENEY
K980839 03/04/1998 AVOCET PT AVOCET MEDICAL, INC. JUDITH BLUNT
K980982 03/17/1998 AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2 AVOCET MEDICAL, INC. JUDITH BLUNT
K980907 03/10/1998 AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY AXIS BIOCHEMICALS, ASA RONALD G LEONARDI
K980812 03/03/1998 IMX HOMOCYSTEINE AXIS BIOCHEMICALS, ASA RONALD G LEONARDI, PH.D.
K980988 03/17/1998 AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) AXYA MEDICAL, INC. HOWARD L SCHRAYER
K981089 03/25/1998 TISSOMAT AND SPRAY SET BAXTER HEALTHCARE CORP. ANGELA BLACKSHERE
K980987 03/17/1998 BECTON DICKINSON SYRINGE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY MORGAN
K980858 03/05/1998 MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS CINDY MORROW
K981013 03/18/1998 VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE BECTON DICKINSON VACUTAINER SYSTEMS EILEEN SCHWEIGHARDT
K981142 03/30/1998 MAICO MA53 BERNAFON-MAICO, INC. SCOTT SAVRE
K980939 03/12/1998 SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K980941 03/12/1998 SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED) BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K980940 03/12/1998 SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K980819 03/03/1998 BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS BIOCIRCUITS CORP. SHEILA J RAMERMAN
K980983 03/17/1998 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOMEDICS CAROL E JONES
K981070 03/24/1998 20-HOLE ADAPTATION PLATE BIOMET, INC. MARY VERSTYNEN
K980927 03/11/1998 LACTOSORB PANELS AND FASTENERS BIOMET, INC. MARY VERSTYNEN
K981083 03/24/1998 RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 BIOTRONIK, INC. LAUREN L FOOTE CHRISTENSEN
K980869 03/06/1998 SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 BIOTRONIK, INC. DAVID MAKANANI
K980971 03/16/1998 BODYSTAT DUALSCAN 2005 BODYSTAT LTD. I J MEEUWSEN
K980853 03/05/1998 CEDIA DAU MULTI-DRUG CALIBRATORS BOEHRINGER MANNHEIM CORP. BETSY SOARES-MADDOX
K980887 03/09/1998 ELECSYS CEA ON THE ELECSYS 1010 BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K980851 03/05/1998 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 BOSTON SCIENTIFIC CORP. DENNIS L WONG
K980795 03/02/1998 UROLOGICAL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. LINDA S POLLITZ
K980920 03/10/1998 EQUINOXE BOUVIER HYDRO, INC. ALAIN JOUAN
K980909 03/10/1998 VICHY SHOWER BOUVIER HYDRO, INC. JOYCE M DUQUETTE
K980962 03/16/1998 BRENNEN MEDICAL BETA GLUCAN CREAM, "MACROPRO" BRENNEN MEDICAL, INC. KENNETH B HERLAND
K980850 03/05/1998 BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS C.R. BARD, INC. SANDRA PERREAND
K980895 03/09/1998 ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI JEFF WHEATON
K981147 03/30/1998 CLEAR (TM) LICE EGG REMOVER SYSTEM CARE TECHNOLOGIES, INC. DANIEL J MANELLI
K981037 03/19/1998 CLEAR (TM) SPECIAL NIT COMB CARE TECHNOLOGIES, INC. DANIEL J MANELLI
K980879 03/09/1998 OSCILLOMATE NIBP / SP02 EMS MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K980965 03/16/1998 SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL CAVEX HOLLAND B.V. BERNARD VAN DUJIN
K981149 03/31/1998 LASETTE LASER SKIN PERFORATOR CELL ROBOTICS, INC. RONALD K LOHRDING
K982230 03/31/1998 LASETTE LASER SKIN PERFORATOR CELL ROBOTICS, INC. RONALD K LOHRDING
K981126 03/27/1998 CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 CERAMOPTEC, INC. JONATHAN S KAHANM ESQ.
K980838 03/04/1998 REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM CERAMOPTEC, INC. JONATHAN S KAHAN
K980826 03/03/1998 EQUIDOSE SOLID STATE DIODE DETECTORS CII MASTEK, INC. JORGE A FERNANDEZ
K980972 03/16/1998 RIGID CULDOSCOPE AND ACCESSORIES CIRCON CORP. RONALD J EHMSEN
K980912 03/10/1998 VCA IGG ELISA TEST SYSTEM CLARK LABORATORIES, INC. WILLIAM L BOTELER JR
K980960 03/16/1998 IN-CHECK INSPIRATORY FLOWMETER CLEMENT CLARKE INTL., LTD. M J WILKINSON
K981157 03/31/1998 STABLE FLOW CMED GREG HOLLAND
K980786 03/02/1998 COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K981047 03/20/1998 FRESH AIR COLORADO MEDTECH, INC. LOCKETT E WOOD
K980787 03/02/1998 HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR COMPUTER MOTION, INC. DOUGLAS P BUESCHEL
K980823 03/03/1998 CORDIS NITINOL STENT AND DELIVERY SYSTEM CORDIS CORP. JOAN MARTIN
K980961 03/16/1998 CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. CORDIS WEBSTER, INC. MARY ADAMS
K980799 03/02/1998 HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL COSMEDENT, INC. MICHAEL O'MALLEY
K980800 03/02/1998 LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL COSMEDENT, INC. MICHAEL O'MALLEY
DEN980001 03/31/1998 DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND CRANIAL TECHNOLOGIES, INC. TIMOTHY R LITTLEFIELD
K981052 03/23/1998 CRESCO TI IMPLANT CONCEPT CRESCO TI SYSTEMS AB PER E NILSSON
K980900 03/10/1998 N-ASSAY CPK-L CRESTAT DIAGNOSTICS, INC. COLIN GETTY
K980883 03/09/1998 N-ASSAY GLU-UL CRESTAT DIAGNOSTICS, INC. COLIN GETTY
K980902 03/10/1998 N-ASSAY L AST/GOT CRESTAT DIAGNOSTICS, INC. COLIN GETTY
K981027 03/19/1998 E.CAM LSO 311 PET/SPECT SYSTEM CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K981098 03/26/1998 STRATUS CS CARDIAC TROPONIN I TESTPAK DADE BEHRING, INC. CAROLYN K GEORGE
K981097 03/26/1998 STRATUS CS CKMB CALPAK DADE BEHRING, INC. CAROLYN K GEORGE
K981101 03/26/1998 STRATUS CS MYO CALPAK DADE BEHRING, INC. CAROLYN K GEORGE
K981102 03/26/1998 STRATUS CS MYOGLOBIN (MYO) TESTPAK DADE BEHRING, INC. CAROLYN K GEORGE
K981099 03/26/1998 STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK DADE BEHRING, INC. CAROLYN K GEORGE
K981100 03/26/1998 STRATUS CS TROP CALPAK DADE BEHRING, INC. CAROLYN K GEORGE
K981226 03/24/1998 IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 DAKO DIAGNOSTICS LTD. RON NEWSTEAD
K980780 03/02/1998 DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE "B" MEMBRANE FOR OPTIONAL SHEATHLES DATASCOPE CORP. WHITNEY TORNING
K980946 03/13/1998 MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP DENTSLEEVE PTY., LTD. MARCUS TIPPETT
K980794 03/02/1998 DUAL LOCK HIP STEM DEPUY, INC. ARLENE C SAULL, RAC
K981059 03/23/1998 ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK, R.T.B.SC
K980833 03/04/1998 IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K981163 03/31/1998 DIAMEDIX IS-CMV IGG TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K981084 03/25/1998 URISCREEN DIATECH DIAGNOSTICS,INC. FRAN WHITE
K980855 03/05/1998 IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT DPC CIRRUS ROBERT M DI TULLIO
K980886 03/09/1998 BABYTHERM 8000 LDR DRAEGER MEDICAL, INC. JAMES J BRENNAN
K980861 03/05/1998 DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY
K980863 03/05/1998 DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY
K980791 03/02/1998 DUMEX PAK-ITS WOVEN RIBBON PACKING DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY
K980777 03/02/1998 DUMEX PAK-ITS-"ABSORBASALT" COTTON GAUZE PACKING DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY, M.SC
K980779 03/02/1998 THALAFIX NATURAL SEA SALT DRESSING DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY, M.SC
K981053 03/23/1998 KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW EASTMAN KODAK COMPANY ROBERT WOLFARTH
K980914 03/11/1998 EMORY CARDIAC TOOL BOX EMORY UNIVERSITY ERNEST V GARCIA
K980854 03/05/1998 RETROGRADE PEDIATRIC NAIL ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K980804 03/02/1998 SABRE BT BLUNT0TIP SURGICAL TROCAR ENDOSCOPIC CONCEPTS, INC. PAMELA PAPINEAU
K980876 03/06/1998 ASTHMA MONITOR AM2 ERICH JAEGER GMBH & CO. KG DETLEF GROTHEER
K980815 03/03/1998 ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC. LORRI CHAVEZ
K981000 03/18/1998 CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN EUROPEAN DENTAL IMPORTS, INC. MICHAEL H EVERNGAM
K981001 03/18/1998 ORION VESTA DENTAL ALLOY EUROPEAN DENTAL IMPORTS, INC. MICHAEL H EVERNGAM
K981002 03/18/1998 ORION WX DENTAL ALLOY EUROPEAN DENTAL IMPORTS, INC. MICHAEL H EVERNGAM
K981143 03/30/1998 DILKES LASER/SUCTION CANNULAE EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K980828 03/03/1998 EXMOOR MYRINGOTOMY KIT EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K981045 03/20/1998 EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K981088 03/25/1998 MILLS COLUMELLA PROSTHESIS EXMOOR PLASTICS LTD. MARGARET BLACKEMORE
K980888 03/09/1998 GLYCACOR EXOCELL, INC. MARGO P COHEN
K980816 03/03/1998 RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES FCI OPHTHALMICS, INC. ANNE BOHSACK
K980822 03/03/1998 TITANIUM PEG SYSTEM FCI OPHTHALMICS, INC. ANNE BOHSACK
K980930 03/12/1998 FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA FIBRA SONICS, INC. ROBERT BROHM
K980963 03/16/1998 HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) FOREMOST DENTAL MFG., INC. AN-SHIH CHENG
K980919 03/11/1998 ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER FORTUNE MEDICAL INSTRUMENT CORP. KAREN U SALINAS
K980917 03/11/1998 ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR FORTUNE MEDICAL INSTRUMENT CORP. KAREN U SALINAS
K980979 03/17/1998 FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K981066 03/24/1998 FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K980808 03/03/1998 ENDO FMS UROLOGY FUTURE MEDICAL SYSTEMS, INC. PATRICK JANIN
K981036 03/19/1998 SMARTBOND GAC INTL., INC. MARK MANNI
K980913 03/10/1998 CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 GALIL MEDICAL LTD. JONATHAN S KAHAN
K981085 03/25/1998 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM GAMBRO HEALTHCARE WILLIAM M TOWNSEND
K980959 03/14/1998 VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS F.I. HAIFA YAIR FRIEDMAN
K980868 03/06/1998 GC IRRIGATOR GENTLE COLONICS, INC. KAREN U SALINAS
K981165 03/31/1998 AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K980857 03/05/1998 MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE GRAPHIC CONTROLS CORP. KATHLEEN SELOVER
K981155 03/31/1998 FLAPMAKER DISPOSABLE MICROKERATOME HAWKEN INDUSTRIES GE0RGE MYERS
K981009 03/18/1998 HEARTPORT ENDOPULMONARY VENT CATHETER HEARTPORT, INC. MARIANNE D DRENNAN
K981081 03/24/1998 BRIGHTSTAR HILL-ROM, INC. WILLIAM D JORDAN
K980840 03/04/1998 LOKKI DT HILLARD W. WELCH HILLARD W WELCH
K980976 03/16/1998 AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP HOLLISTER, INC. JOESEPH S TOKARZ
K980985 03/17/1998 SCMD-1000 HOWARD INSTRUMENTS, INC. JACK W HOWARD
K980926 03/11/1998 DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION HOWMEDICA CORP. MARGARET F CROWE
K980925 03/11/1998 DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION HOWMEDICA CORP. MARGARET F CROWE
K980843 03/04/1998 EXETER INTRAMEDULLARY BONE PLUG HOWMEDICA, INC. FRANK MASS
K980813 03/03/1998 RELIANCE LONG STEM FEMORAL COMPONENTS HOWMEDICA, INC. FRANK MAAS
K981153 03/30/1998 OSIRIS HUESTIS MEDICAL TERRY CHWALK
K981062 03/23/1998 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES IDEAL QUALITY SDN., BHD. LIM LENG BUNG
K980781 03/02/1998 IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS IMPLEX CORP. ROBERT POGGIE, PH.D.
K981076 03/24/1998 VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT IMPRA, INC. KRISTI M KISTNER
K981079 03/24/1998 VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT IMPRA, INC. KRISTI M KISTNER
K980989 03/16/1998 3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING INNOVATIVE TECHNOLOGIES LTD. ANNA E MCRIGHT
K981166 03/31/1998 ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 INRAD ANNE ARMSTRONG
K980999 03/18/1998 ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT INSTRUMENT MAKAR, INC. LANNY J JOHNSON
K981038 03/19/1998 COAMATIC FACTOR VIII INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K980875 03/06/1998 IL TEST PROTEIN C INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K981069 03/24/1998 ULTRA-COVER PU-TRANSDUCER COVER INTERNATIONAL MEDICAL PRODUCTS B.V. H.G TE SINKEL
K981003 03/18/1998 ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES INTERNATIONAL MEDICAL PRODUCTS, INC. JEFFREY R SHIDEMAN
K980817 03/03/1998 PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L INTERPORE INTL. DAVID P BALDING
K981112 03/26/1998 MOBETRON INTRAOP MEDICAL, INC. DONALD A GOER
K980783 03/02/1998 SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 IRT MANAGEMENT CORP. NICHOLAS G LEVANDOSKI, PH.D.
K980922 03/11/1998 PROTEC CEM. IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K980986 03/17/1998 PROCAD IVOCLAR USA, INC. PETER P MANCUSO
K980953 03/13/1998 ACCU-BITE HOME KIT DISCLUDER JEROME M. SIMON JEROME M SIMON
K980778 03/02/1998 HAKIM MICRO PROGRAMMABLE VALVE SYSTEM JOHNSON & JOHNSON PROFESSIONALS, INC. DIANE MINEAR
K980801 03/02/1998 J-FX BIPOLAR HEAD JOHNSON & JOHNSON PROFESSIONALS, INC. MARY E GRAY
K980852 03/05/1998 GII SPINAL FIXATION SYSTEM KAREN E. WARDEN, M.E.B.E. KAREN E WARDEN
K981130 03/30/1998 KSEA ENDO TIP SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K980878 03/09/1998 PULMOTRACK,MODEL 1010 KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. CHARLES S IRVING
K980908 03/10/1998 LACTATE PRO SYSTEM KDK CORP. KAZUO IKETAKI
K980899 03/10/1998 JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID KENSHIN TRADING CORP. KUNIO SUZUKI
K980803 03/02/1998 STERILE POWDER-FREE LATEX EXAMINATION GLOVES KENWELL INTERNATIONAL LTD. SUSAN D GOLDSTEIN-FALK
K980873 03/06/1998 KONICA DIRECT DIGITIZER REGIUS MODEL 330 KONICA CORP. RUSSELL D MUNVES
K980980 03/17/1998 MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 KONIGSBERG INSTRUMENTS, INC. ARLIN HANSON
K981063 03/23/1998 AUTOMATED CORNEAL TREPHINE LASER CENTER DEV. CORP. FRANCIS E O'DONNELL, JR.
K981090 03/26/1998 LASERLITE DIODE SURGICAL LASER LASERLITE, LLC. MAUREEN O'CONNELL
K981159 03/31/1998 PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES LATEXX PARTNERS BHD. GOH SEE KHEK
K980957 03/16/1998 KAPLAN-SIMPSON INFUSASLEEVE II (100) OR IS-2 (100) LOCALMED, INC. AARON KAPLAN
K980942 03/12/1998 REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE LONDON INTERNATIONAL GROUP, INC. NEIL ANDERSON
K980785 03/02/1998 STERILE, POWDERFREE LATEX EXAMINATION GLOVE LONDON INTL. LLC. NEIL ANDERSON
K980968 03/16/1998 LONE STAR IMPRESSION SYSTEMS LONE STAR TECHNOLOGIES EDWARD SPEHAR
K980964 03/16/1998 MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS LS RUBBER SDN BHD MOHAMAD FIRDAOS BIN MOHAMED
K980809 03/03/1998 LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER LUMISYS, INC. GARY J ALLSENBROOK
K981024 03/19/1998 QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) MARQUETTE MEDICAL SYSTEMS, INC. KRISTIN PABST
K980845 03/04/1998 MS-900S, MS-900SPM & MS-900SFM MARS MEDICAL PRODUCTS E J SMITH
K981061 03/23/1998 INTRAVASCULAR RETRIEVAL DEVICE MED INSTITUTE, INC. NEAL FEARNOT
K981071 03/24/1998 ML MICROKERATOME MED-LOGICS, INC. BETTY ROSS
K981073 03/24/1998 MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK MEDCOM LAUNDRY SERVICE, INC. GARY VANDRIEL
K980990 03/17/1998 POLYCARBOXYLATE CEMENT MEDENTAL INTL. DEBRA OLSON
K981125 03/27/1998 MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 MEDICAL COMPONENTS, INC. JEANNE M CUSH
K980904 03/10/1998 MUCHECK MONITOR UNIT VALIDATION PROGRAM MEDICAL DOSIMETRY SERVICES, INC. GREGORY MILLER
K981032 03/19/1998 PIV SYSTEM MEDICAL SOLUTIONS, INC. E J SMITH
K981119 03/27/1998 CARDIOPAL MODEL NUMBER PM20 MEDICOMP, INC. JOSEPHUS RIFFE
K981094 03/26/1998 MEDRAD NEUROVASCULAR COIL MEDRAD, INC. RODNEY J RYLANDS
K981046 03/20/1998 MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 MEDTRONIC PS MEDICAL RICHARD M RUEDY
K980973 03/16/1998 MEDTRONIC ANGIOGRAPHIC CATHETER MEDTRONICS INTERVENTIONAL VASCULAR MARK CHARTIER
K981023 03/19/1998 KLEENASEPTIC METREX RESEARCH CORP. WENDY A URTEL
K980859 03/05/1998 HEMOCOR HPH MINI HEMOCONCENTRATOR MINNTECH CORP. MARK MURPHY
K981140 03/30/1998 MINRAD DRTS LIGHT SABER SYRINGE MINRAD, INC. THOMAS L PARKER
K980948 03/13/1998 VED VALU- VACUUM ERECTION DEVICE MISSION PHARMACAL COMP ANDREW I SEALFON
K981048 03/20/1998 HYDRAGEL 6 CSF KIT MORAX BOREK JANIK, PH.D.
K980937 03/12/1998 NICORE MODEL ESP -1 NICORE EQUIPMENT & LEASING, INC. MICHAEL G FARROW
K980814 03/03/1998 PURESPERM NIDACON INTERNATIONAL AB DANIEL KAMM
K980991 03/17/1998 NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K980842 03/04/1998 COPPER TONGUE SCRAPER ONTEL PRODUCTS CORP. MIKE K LAKHIANI
K981114 03/27/1998 MICROCAP ORIDION MEDICAL LTD. SANFORD BROWN
K980864 03/05/1998 POWER COINS GLOW IN THE DARK LIGATURES ORTHO KINETICS CORP. STEVEN O LUSE
K980952 03/13/1998 SNORE-CURE ANTI-SNORING APPLIANCE ORTHO-TAIN, INC. DAVID L ROSEN
K980981 03/17/1998 OMEGA "HA" COATED TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K980774 03/02/1998 OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS OSTEONICS CORP. KATE SUTTON
K981164 03/31/1998 POWDER FREE CHLORINATED GLOVES-(TEXTURED) PAN-CENTURY RUBBER PRODUCTS SDN. BHD. H.R.K. MURTHY
K981109 03/27/1998 QUITETIP PARADIGM MEDICAL INDUSTRIES, INC. RICHARD DIRKSON
K980955 03/13/1998 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K980797 03/02/1998 PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR PEREGRINE SURGICAL LTD. TODD RICHMOND
K980916 03/11/1998 "POWDER-FREE" LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM PERUSAHAAN GETAH ASAS SDN BHD BOB CHAN
K980997 03/17/1998 PGK DEVICE (MODIFIED) PGK, INC. PANOS G KOUTROUVELIS
K980896 03/09/1998 QUICKCARD PRO HCG TEST, MODEL 9008 PHAMATECH CARL A MONGIOVI
K980865 03/06/1998 QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 PHAMATECH TUAN PHAM
K980831 03/04/1998 IMAGE POST-PROCESSING TECHNIQUES PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K980918 03/11/1998 JPACS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K980820 03/03/1998 PHILIPS EASYGUIDE PHILIPS MEDICAL SYSTEMS, INC. FRANK GIANELLI
K980977 03/16/1998 PIOLAX HYDROPHILIC GUIDEWIRE PIOLAX MEDICAL DEVICES, INC. ELIZABETH BIERMAN
K980924 03/11/1998 PLANCON MICROLAMELLAR KERATOME EVOLUTION PLANCON INSTRUMENTS ALAIN DUPRAT
K980974 03/16/1998 SAFE MINI POLYSTAN A/S THOMAS ANDERSEN
K981011 03/18/1998 POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) POS-T-VAC, INC. MARK A HELLER
K981015 03/18/1998 PALI-TRODE PREFERRED INSTRUMENTS CHARLES W SCOUTEN, PH.D.
K980798 03/02/1998 BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST PRINCETON BIOMEDITECH CORP. JEMO KANG, PH.D.
K980848 03/04/1998 HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED PT. IRAMA DINAMIKA LATEX ANIL TANEJA
K981064 03/23/1998 POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES PT. IRAMA DINAMIKA LATEX ANIL TANEJA
K980811 03/03/1998 SERAQUEST ANTI-SM/RNP QUEST INTL., INC. ROBERT A CORT
K980810 03/03/1998 SERAQUEST ANTI-SSA QUEST INTL., INC. ROBERT A CORT
K980898 03/09/1998 FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER RADI MEDICAL SYSTEMS AB MATS GRANLUND
K980903 03/10/1998 RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT RADIONICS, INC. MICHAEL A ARNOLD, PH.D
K981055 03/23/1998 XKNIFE-4 RADIONICS, INC. LISA MISTERKA BENATI
K981072 03/24/1998 ESPRIT VENTILATOR RESPIRONICS, INC. PAUL WOODRING
K980996 03/17/1998 COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) ROCHE DIAGNOSTIC SYSTEMS, INC. JAMES W HAYNES
K980792 03/02/1998 CU-100A LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. STERLING CHENG
K980793 03/02/1998 Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. STERLING CHENG
K981169 03/30/1998 RONDEX CPR ISO-SHIELD RONDEX PRODUCTS, INC. GENE R BALDWIN
K980870 03/04/1998 RUSCH SILICONE FOLEY CATHETER RUSCH, INC. JAMES R WHITNEY
K980784 03/02/1998 SURETOUCH SAHAR TECHNOLOGIES, INC. GARY SHAFFER
K980782 03/02/1998 STAT-SIMPLE PYLORI SALIVA DIAGNOSTIC SYSTEMS, INC. PAUL D SLOWEY
K981141 03/30/1998 SARGON IMMEDIATE LOAD IMPLANT, MODEL D SARGON ENT., INC. DANIEL J MANELLI
K981124 03/27/1998 ACCUDEXA BONE DENSITOMETER SCHICK TECHNOLOGIES, INC. T. WHIT ATHEY
K981096 03/25/1998 SEMPERMED SURGEONS' GLOVES - SUPREME SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT RICHARD EHRENFELDNER
K981133 03/20/1998 POWDERED NITRILE EXAMINATION GLOVES SERVICOM SERVICES SDN BHD N.S. KUMAR
K980885 03/09/1998 SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K980837 03/04/1998 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS SHIMADZU MEDICAL SYSTEMS MICHAEL FISHBACK
K980882 03/09/1998 SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR SIEMENS MEDICAL SOLUTIONS USA, INC. JACQUELINE E.M. EMERY
K980884 03/09/1998 SIEMENS SEVOFLURANE VAPORIZER SV 953 SIEMENS MEDICAL SOLUTIONS USA, INC. DAVID SIMARD
K981035 03/19/1998 PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES SIMS PORTEX, INC. TIMOTHY J TALCOTT
K981034 03/19/1998 SILENT NIGHT II SLEEP SOLUTIONS, INC. LISA S JONES
K981156 03/31/1998 DYONICS INTELIJET INFLOW/OUTFLOW CANNULA SMITH & NEPHEW, INC. DEBORAH J CONNORS
K981115 03/27/1998 RADIO-PLAST SMITH & NEPHEW, INC. CORDELL C HOFFINS
K980841 03/04/1998 RCI FIXATION SCREWS SMITH & NEPHEW, INC. DEMETRIOS TSAKONAS
K981150 03/31/1998 SOLOSITE GEL CONFORMABLE DRESSING SMITH & NEPHEW, INC. JIM G IRVIN
K981043 03/20/1998 DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL SOLUTION TECHNOLOGIES WILLIAM J GRISWOLD, JR
K981028 03/19/1998 ULTRA IMAGE AND ULTRA SCAN SONOTECH, INC. MARGARET J LARSON
K981004 03/18/1998 SLE EMG ELECTRODES AND ACCESSORIES SPECIALIZED LABORATORY EQUIPMENT, LTD. FRANK FERGUSON
K981039 03/19/1998 POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) SRI JOHANI SDN. BHD. LIM L AIK
K980818 03/03/1998 POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) STEPHEN A. DUNN, INC. MARTIN S KNOPF
K980829 03/04/1998 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP STERIPAK, LTD. JASON A GROSS
K980970 03/16/1998 IIRAD DIRECTRAY OPERATOR CONSOLE STERLING DIAGNOSTIC IMAGING, INC. JEAN E BARTLETT
K980951 03/13/1998 ONEFLOW STI MEDICAL LAUREN R ZIEGLER
K980966 03/16/1998 SUPERGLOVES POWDERED NITRILE SUPERMAX SDN BHD STANLEY THAI
K981041 03/20/1998 SLT BIPOLAR SHEATH SURGICAL LASER TECHNOLOGIES, INC. MONICA FERRANTE
K981075 03/24/1998 SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET SYNTHES (USA) SHERI L MUSGNUNG
K980944 03/12/1998 SYNTHES SCHUHLI IMPLANT SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K980928 03/11/1998 SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM SYNTHES SPINE BARRY E SANDS
K981019 03/18/1998 QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST SYNTRON BIORESEARCH, INC. CLEVE W LAIRD
K980776 03/02/1998 ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST TCPI, INC. CLEVE W LAIRD
K981106 03/26/1998 UREA NITROGEN (BUN) LIQUID REAGENT TECO DIAGNOSTICS RHODA FILIPINA
K980796 03/02/1998 TERUMO ALLERGY SYRINGE TERUMO CORP. KRISTINE WAGNER
K980935 03/12/1998 CAPIOX SX HARDSHELL RESERVOIR TERUMO MEDICAL CORP. SANDI HARTKA
K981030 03/19/1998 BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT THE BINDING SITE, LTD. JAY H GELLER
K981029 03/19/1998 BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT THE BINDING SITE, LTD. JAY H GELLER
K981008 03/18/1998 SIMAL CERVICAL STABILIZATION SYSTEM TOP SURGICAL PRODUCTS GMBH KARENANN J BROZOWSKI
K981012 03/18/1998 AIA-PACK MYOGLOBIN ASSAY TOSOH MEDICS, INC. LORI ROBINSON
K981123 03/27/1998 UREA TRACE SCIENTIFIC LTD.
K980906 03/10/1998 TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO TRANSONIC SYSTEMS, INC. CORNELIS J DROST
K981080 03/24/1998 SCOOP 1 TRANSTRACHEAL SYSTEMS LESIS WARD
K981078 03/24/1998 TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 TRANSTRACHEAL SYSTEMS LEWIS WARD
K980827 03/03/1998 LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING TUCKER & ASSOCIATES JANNA P TUCKER
K980802 03/02/1998 NITRILE EXAM GLOVE, POWDER-FREE, BLUE TUCKER & ASSOCIATES JANNA P TUCKER
K981128 03/30/1998 SOFSILK SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JAMIE YIEH
K980862 03/05/1998 TITANIUM SPINAL ROD SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SHARON L MURPHY
K980889 03/09/1998 URESIL NEPHRO-URETERAL STENT URESIL CORP. LEV MELINYSHYN
K980915 03/11/1998 VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM VALLEYLAB, INC. CHARLES M COPPERBERG
K981056 03/23/1998 VARIAN XIMATRON SCAN VISION CT VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K980994 03/17/1998 IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES VENETEC INTL., INC. ANITA PELLETIER
K980992 03/17/1998 IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES VENETEC INTL., INC. GRACE HOLLAND
K981051 03/18/1998 SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES W.L. GORE & ASSOCIATES,INC JOHN W NICHOLSON
K981093 03/26/1998 WESCO BLANKET WESCO, INC. ARLEN C WEST
K980821 03/03/1998 HELICOBACTER PYLORI IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K981021 03/19/1998 ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K981020 03/19/1998 ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K981120 03/27/1998 ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K981014 03/18/1998 ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K981091 03/25/1998 NEOCOLLOID, ORTHOPRINT ZHERMACK S.P.A. EVAN DICK


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