FDA 510(k) Applications Received During June, 1998

FDA 510(k) Number Submission Date Device Name Applicant Contact
K982275 06/29/1998 RAPPORT V.T.D. *OWNE MUMFORD USA, INC.** ROBERT SHAW
K982142 06/17/1998 MOUNTABLE ENDOSCOPIC KNIFE A.M. SURGICAL, INC. EUGENE T KING
K982094 06/15/1998 VERABOND 2 AALBA DENT, INC. VINCENT BENETTI
K982159 06/19/1998 ABBOTT PLUM A+ INFUSION PUMP ABBOTT LABORATORIES DAVID T GUZEK
K981920 06/01/1998 AMM ABBOTT LABORATORIES MARK LITTLEFIELD
K981943 06/03/1998 DBIL ABBOTT LABORATORIES MARK LITTLEFIELD
K982041 06/10/1998 UIBC ABBOTT LABORATORIES LINDA MORRIS
K981918 06/01/1998 UREA ABBOTT LABORATORIES MARK LITTLEFIELD
K981905 06/01/1998 STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 ACU-PAK CAROL THOMPSON
K981936 06/02/1998 ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION ADVANCED BIOMEDICAL DEVICES, INC. R. EDWARD WINTERS
K981999 06/08/1998 ALBATECH PERSONAL MONITOR ALBATECH, INC. SHERYL S NATELSON
K982269 06/29/1998 CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA ALLEGIANCE HEALTHCARE CORP. ZARINA B ILGRAMI
K982051 06/11/1998 KELOCATE SHEETING ALLIED BIOMEDICAL CORP. CATHERINE RIPLE
K982063 06/12/1998 ALM PRISMALIX (PRX) SURGICAL LIGHT ALM SURGICAL EQUIPMENT, INC. SUSAN NIELSEN
K982218 06/24/1998 NITRILE POWDER-FREE UNISEAL GLOVES AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD TARANI DEVI
K981979 06/05/1998 UNISEAL GLOVES LOW PROTEIN POWDERED AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD TARANI DEVI
K982221 06/24/1998 PREMIER AP AMERICAN IMEX JOE FONG
K982029 06/09/1998 SHARPS COLLECTION CONTAINER - SAF-T-SHELL AMERICAN MEDICAL MFG., INC. MIKE HOFTMAN
K982076 06/12/1998 AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM AMIRA MEDICAL, INC. DAVID A HASKER
K982073 06/12/1998 ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM ANCHOR PRODUCTS CO. ROBERT H THRUM
K982131 06/17/1998 NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE ANSELL EDMONT INDUSTRIAL, INC. MIKE W HAGANS
K982239 06/23/1998 CIRCUIT GUARD ARC MEDICAL, INC. HAROLD B NORRIS
K982141 06/17/1998 ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 ARROW INTL., INC. THOMAS D NICKEL
K981967 06/04/1998 WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE ARTHROTEK/BIOMET, INC. PATRICIA SANDBORN BERES
K982274 06/29/1998 NITRILE PATIENT EXAMINATION GLOVE POWDER FREE ASIA PACIFIC LATEX SDN BHD LEE SOON HONG
K982287 06/30/1998 ASLAN SENSOR MODULAR INSTRUMENT ASLAN MEDICAL TECHNOLOGIES, LTD. THOMAS J HOOGEBOOM
K982288 06/30/1998 RADIAL HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K982268 06/29/1998 ULNAR HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K981909 06/01/1998 BAXTER HEMOSTASIS VALVE INTRODUCERS BAXTER EDWARDS SCOTT BEGGINS
K982102 06/15/1998 SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY BAXTER HEALTHCARE CORP. VICKI L DREWS
K982219 06/24/1998 MICROALBUSTIX REAGENT STRIPS BAYER CORP. ROSANNE M SAVOL
K981939 06/02/1998 AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR BCI INTL., INC. DONALD J ALEXANDER
K982279 06/30/1998 VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 BCI INTL., INC. DONALD J ALEXANDER
K981985 06/05/1998 ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 BECKMAN COULTER, INC. ELLEN M VOSS
K982022 06/09/1998 VIGIL HEMOGLOBIN (HBALC) CONTROLS BECKMAN COULTER, INC. LUCINDA STOCKERT
K982224 06/24/1998 VIGIL PROTEIN CONTROL BECKMAN COULTER, INC. RICHARD T ROSS
K982250 06/26/1998 ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC. SHELLIE GUST
K982284 06/30/1998 POWDERED GREEN LATEX EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE AIK LIM
K982285 06/30/1998 POWDERFREE GREEN LATEX EXAMINATION GLOVES BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K982286 06/30/1998 POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) BESGLOVE MEDICARE SDN. BHD. LEE A LIM
K982238 06/25/1998 BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 BINAX, INC. PAMELA S ANGELL
K982036 06/10/1998 SILON SCAR STRIPS BIO MED SCIENCES, INC. MARK E DILLON
K982282 06/30/1998 DURA-GUARD - DURAL REPAIR PATCH BIO-VASCULAR, INC. MARY FRICK
K982095 06/15/1998 LACTOSORB MENISCAL REPAIR DEVICE BIOMET, INC. MARY L VERSTYNEN
K981996 06/08/1998 TITANIUM FEMORAL COMPONENT BIOMET, INC. FRED MCCLURE
K982139 06/17/1998 BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM BIONX IMPLANTS, INC. JOHNATHAN S KAHAN
K982245 06/26/1998 TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA BIOSITE INCORPORATED JOHN F BRUNI
K982111 06/16/1998 VARIOUS DENTAL IMPLANTS BIOTECH MEDICAL INSTRUMENTS CORP. WILLIAM SIMMONS
K982272 06/29/1998 GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 BIOTRONIK, INC. DAVID MAKANANI
K981971 06/04/1998 TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 BIRD PRODUCTS CORP. NEIL BATTISTE
K982034 06/10/1998 E-FAX SYSTEM BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS J. HARVEY KNAUSS
K982132 06/17/1998 BLEASE 6200 ANAESTHESIA VENTILATOR BLEASE MEDICAL EQUIPMENT LTD. FRANCIS X CASEY
K982137 06/17/1998 BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE BLEASE MEDICAL EQUIPMENT LTD. FRANCIS X CASEY
K982079 06/15/1998 ACCU-CHECK VOICEMATE BOEHRINGER MANNHEIM CORP. MIKE FLIS
K982089 06/15/1998 ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS BOEHRINGER MANNHEIM CORP. MIKE FLIS
K982002 06/08/1998 ACCU-CHEK COMFORT CURVE TEST STRIP BOEHRINGER MANNHEIM CORP. MIKE FLIS
K981947 06/03/1998 STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) BOSTON MEDICAL CORP. TIMOTHY F HAND
K981981 06/05/1998 ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 BOSTON SCIENTIFIC CORP. STEVE JWANOUSKOS
K982077 06/12/1998 SELECTOR DIAGNOSTIC CATHETER BOSTON SCIENTIFIC SCIMED, INC. JANELL A COLLEY
K982184 06/22/1998 WALLSTENT ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC. PHILIP B JARVI
K982005 06/08/1998 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC. RONALD W BENNETT
K981969 06/04/1998 ULTIMA BODY POSITION SENSOR BRAEBON MEDICAL CORP. RICHARD A BONATO
K982216 06/23/1998 ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 BRAEBON MEDICAL CORP. RICHARD A BONATO
K982043 06/10/1998 BRENEB BREMED ITALIA, S.R.L. MARK HEBENSTREIT
K982158 06/19/1998 SCOUT BURKE, INC. DUWAYNE E KRAMER
K981994 06/08/1998 VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER C.R. BARD, INC. PEGGY KEIFFER
K982243 06/25/1998 CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 CANOGEN INTERNATIONAL LTD. MELISSA MAHALL
K982283 06/30/1998 WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH CARADYNE, LTD. PAUL E DRYDEN
K982174 06/17/1998 VENTURI VENTILATOR CARDIOPULMONARY CORP. JAMES W BIONDI
K982135 06/17/1998 OSCILLOMATE EMS NIBP MONITOR MODEL 9001 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K982151 06/18/1998 STERITITE PROCESS INDICATOR ACCESSORIES CASE MEDICAL, INC. MARCIA FRIEZE
K981970 06/04/1998 ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI CAVEX HOLLAND B.V. BERNARD VAN DUIJN
K981972 06/04/1998 GREEN-OR DENTIN DESENSITIZER CENTRIX, INC. JOHN DISCKO
K981913 06/01/1998 PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY CHEMBIO DIAGNOSTIC SYSTEMS, INC. RAYMOND DATTWYLER
K982168 06/19/1998 SOLO-CARE BRAND MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K981989 06/05/1998 THE WAVE DIGITAL PHACO SYSTEM CIRCUIT TREE MAURICE IMONTI
K982053 06/11/1998 EEG ELECTRODES MODEL "445 SERIES" CLASS A ENT. JANICE A AUDI
K982254 06/26/1998 COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K982116 06/16/1998 AQUACEL HYDROFIBER WOUND DRESSING CONVATEC, A BRISTOL-MYERS SQUIBB CO. AMEER ALLY
K981906 06/01/1998 MODIFICATION FOR PTA BALLOON CATHETER COOK, INC. APRIL LAVENDER
K982280 06/30/1998 CRYOPRO MAXI AND CRYOPRO MINI CORTEX TECHNOLOGY APS MARSHA WERTZBERGER
K982172 06/19/1998 CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL COULTER CORP. MARION S GIDE
K982167 06/19/1998 CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 COULTER CORP. MARION S GAIDE
K982166 06/19/1998 CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 COULTER CORP. MARION S GAIDE
K982055 06/11/1998 ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 CRYOMEDICAL SCIENCES, INC. RICHARD J REINHART
K981962 06/04/1998 CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE CUDA PRODUCTS CO. JOSEPH CUDA
K981990 06/08/1998 MRS-400, MAXI 400, MRSL-400, MAXI 400L D.B.I. AMERICA CORP. UBIRACI R FERNANDES
K982210 06/23/1998 MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA DADE BEHRING, INC. PAUL ROGERS
K982292 06/30/1998 PREALBUMIN CALIBRATOR DADE BEHRING, INC. REBECCA S AYASH
K982187 06/22/1998 FAST-CATH INTRA-CARDIAC INTRODUCER DAIG CORP. DEAN BRUHN-DING
K982154 06/19/1998 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM DANEK MEDICAL, INC. RICHARD W TREHARNE
K982091 06/15/1998 CS/3 COMPACT AIRWAY MODULE, M-COVX DATEX-ENGSTROM, INC. JOEL C KENT
K981956 06/04/1998 DEGANIA SILICONE IDENTI LOOPS DEGANIA SILICONE, LTD. BETTE LUBIN
K981934 06/02/1998 THE BAGNOLI-4 EMG SYSTEM DELSYS, INC. GIANLUCA DE LUCA
K981948 06/03/1998 APOLLO 95E DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. GREG HOLLAND
K981965 06/04/1998 FLOWABLE COMPOSITE DENTSPLY INTL. P. JEFFREY LEHN
K982007 06/08/1998 TRUBYTE DENTURE BOND DENTURE BONDING AGENT DENTSPLY INTL. P J LEHN
K982011 06/08/1998 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K981941 06/02/1998 MULTAPORT CANNULA REDUCER AND ACCESSORIES DEXIDE, INC. LYNETTE CALDWELL
K981940 06/02/1998 MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES DEXIDE, INC. LYNETTE CALDWELL
K982078 06/15/1998 IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K982027 06/02/1998 MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY DIASORIN, INC. JUDITH J SMITH
K982169 06/19/1998 SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K982003 06/08/1998 DS30 HCY HOMOCYSTEINE ASSAY KIT DREW SCIENTIFIC LTD. ANDREW KENNEY
K981911 06/01/1998 PROFA DUNCAN HYND ASSOCIATES, LTD. DIANA UPTON
K982241 06/25/1998 BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX DUXBURY SCIENTIFIC INC. ROBERT M ENGLER
K982134 06/17/1998 DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 DYNAMIC TECHNOLOGY CORP. YAW C YANG
K982060 06/11/1998 VOLUMAX CT IMAGING SYSTEM ELSCINT, INC. STEVEN M KAY
K981926 06/02/1998 ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS EMD CHEMICALS INC. ANNA G BENTLEY
K982178 06/22/1998 VAGABOND SOFT RESTRAINT SYSTEM EMERGENT INNOVATIONS, LTD. DUANE R ELLIOTT
K982059 06/11/1998 ROTECNO 2000 SURGICAL GOWN ENCOMPASS GROUP, LLC. TIM CUMMINS
K982058 06/11/1998 ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN ENCOMPASS GROUP, LLC. TIM CUMMINS
K982160 06/19/1998 HINGED KNEE ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K982119 06/16/1998 DIODE LASER ESC MEDICAL SYSTEMS LTD. ZVI LADIN
K982129 06/17/1998 ANTAGON PORCELAIN EUROPEAN DENTAL IMPORTS, INC. MICHAEL H EVERNGAM
K982118 06/03/1998 CARESIDE ANALYZER EXIGENT DIAGNOSTICS, INC. KENNETH B ASARCH
K981899 06/01/1998 CARESIDE HDL-CHOLESTEROL EXIGENT DIAGNOSTICS, INC. KENNETH B ASARCH
K982157 06/19/1998 TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE FIELD EFFECTS GREG HURST
K982170 06/19/1998 FLUIDSENSE FLUID DELIVERY SYSTEM FLUIDSENSE CORP. ERIC BRENNAN
K982201 06/22/1998 ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) FOREMOST DENTAL MFG., INC. D T WOLF
K981928 06/02/1998 GALILEO DISPOSABLE ENDOSCOPES GALILEO ELECTRO-OPTICS CORP. MARY MCNAMARA-CULLINANE
K982196 06/22/1998 DIGITAL RADIOGRAPHIC IMAGING SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K982004 06/08/1998 CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS GENERAL ELECTRIC CO. LARRY A KROGER
K981964 06/04/1998 MEDI-TRACE 4103 NEONATAL ELECTRODE GRAPHIC CONTROLS CORP. SUSAN KRASNY
K981919 06/01/1998 BISSINGER CABLES, CAT. NO. 801000XX GUENTER BISSINGER MEDIZINTECHNIK GMBH DAGMAR S MASER
K982083 06/15/1998 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. LORNA TSUDA
K982057 06/11/1998 BC 900 SLIT LAMP HAAG-STREIT AG JUERG H SCHNETZER
K982171 06/19/1998 HAMAMATSU PET SCANNER, MODEL SHR-22000 HAMAMATSU PHOTONICS, K.K. T. WHIT ATHEY
K981954 06/04/1998 VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS HEALTHLINE IMPLANTS, INC. WILLIAM SIMMONS
K981995 06/08/1998 QUICKDRAW VENOUS CANNULA HEARTPORT, INC. MARIANNE C DRENNAN
K982025 06/09/1998 HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR HEWLETT-PACKARD CO. RICHARD J PETERSEN
K982068 06/12/1998 HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM HOWMEDICA CORP. SEAN LULAND
K982248 06/26/1998 HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A HOWMEDICA, INC. FRANK MAAS
K982266 06/29/1998 HYDROCISION ARTHROJET SYSTEM HYDROCISION, INC. ERIC BANNON
K982071 06/12/1998 I-STAT LACTATE TEST I-STAT CORP. PAUL VANDRWERF
K982249 06/26/1998 INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) DONNA WARD
K982155 06/18/1998 SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM INFLUENCE, INC. JONATHAN S KAHAN
K982234 06/25/1998 AL-GEN CALCIUM ALGINATE DRESSING INNOVATIVE TECHNOLOGIES LTD. CJ OAKES
K982023 06/09/1998 PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT INOVA DIAGNOSTICS, INC. BRYS C MYERS
K981952 06/03/1998 COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER INSTRUMENTS FOR MEDICINE AND DIAGNOSTICS WILLIAM J MCMAHAN
K982180 06/22/1998 DURAGEN DURAL GRAFT MATRIX INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K982064 06/12/1998 ACTION STORM RANGER II, ACTION STORM POWER 9000 INVACARE CORP. EDWARD A KROLL
K982242 06/25/1998 INVACARE CPAP INVACARE CORP. EDWARD A KROLL
K982031 06/10/1998 OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE IRIDEX CORP. DANIEL MARINSIK
K982232 06/25/1998 MODIFICATION OF THE "IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM" IRVINE BIOMEDICAL, INC. ROGER TU
K982044 06/10/1998 NUCAMMA R+ IS2 RESEARCH, INC. PETER SCHULTZ
K982045 06/10/1998 NUCAMMA RX IS2 RESEARCH, INC. PETER SCHULTZ
K982042 06/10/1998 ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 ISLAND BIOSURGICAL, INC. HUNTER A MCKAY
K982255 06/26/1998 MODEL 2000 PULSE OXIMETER IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K982208 06/23/1998 IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER JOMED IMAGING LTD. CAROLINE SHORT
K982176 06/22/1998 KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR KIRWAN SURGICAL PRODUCTS, INC. KEVIN PRARIO
K982259 06/26/1998 CHROMA ZONE COLOR STAIN KURARAY AMERICA, INC. KOJI FUJITA
K982164 06/19/1998 ESTENIA KURARAY AMERICA, INC. KOJI FUJITA
K981955 06/04/1998 MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS LS RUBBER SDN BHD RAJIL VOHRA
K982267 06/29/1998 DPX-RX BONE DENSITOMETER LUNAR CORP. KENNETH D BUROKER
K982114 06/16/1998 LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES M/S MIDLAND LATEX PRODUCTS LTD. ANIL SEGAT
K981898 06/01/1998 ORTHOVU-1000 MAGNEVU BOB ROSE
K981942 06/02/1998 LATEX POWDER FREE EXAMINATION GLOVES MAIKA RUBBER PRODUCTS SDN BHD RAVI ANBIL
K982260 06/26/1998 MARKWELL GAUZE SPONGE MARKWELL INTL., INC. SEAN WANG
K982256 06/26/1998 OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP MCKINLEY, INC. SUZANNE DENNIS
K981992 06/08/1998 ELECTRON WEDGE MODEL MT-EW-1000 MED-TEC,INC. DONALD F RIIBE
K982191 06/22/1998 CHEMICAL CURE COMPOSITE WITH ENAMEL BOND MEDENTAL INTL. DEBRA OLSON
K982123 06/16/1998 CONTRAST CONTROL DEVICE MEDEX, INC. CINDY CHENETSKI
K982024 06/09/1998 OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. SCOT KINGHORN
K981933 06/02/1998 URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 MEDICAL ANALYSIS SYSTEMS, INC.
K982104 06/15/1998 ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 MEDICAL DATA ELECTRONICS DAVID M TRUEBLOOD
K982085 06/15/1998 MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K982215 06/23/1998 MANUAL RESUSCITATOR WITH ACE MEDICAL MARKETING CONCEPTS E J SMITH
K982047 06/10/1998 MPS HUBER NEEDLE EXTENSION SET MEDICAL PRODUCT SPECIALISTS DAN HYUN
K982048 06/10/1998 MPS RESERVOIR BAG MEDICAL PRODUCT SPECIALISTS DAN HYUN
K982211 06/23/1998 PROFILE-II MODEL 600582 MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K982755 06/29/1998 MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG) MEDTRONIC BLOOD MANAGEMENT STEPHEN MCKELVEY
K982220 06/24/1998 MODEL 2872 BIPOLAR LEAD ADAPTOR KIT MEDTRONIC VASCULAR BRIAN J EDWARDS
K982145 06/17/1998 MEGA 3 MEGA MOTION, INC. PAUL GRONKA
K982144 06/17/1998 MEGA 4 MEGA MOTION, INC. PAUL GRONKA
K982066 06/11/1998 MP-3 POWER BASE CHAIR MERITS HEALTH PRODUCTS., INC. WINSTON ANDERSON
K982020 06/09/1998 METRON QA-IDS I.V. PUMP TESTER METRON U.S., INC. E.J. SMITH
K982013 06/08/1998 MGB LAPALUX TELESCOPE MGB ENDOSKOPISCHE GERATE GMBH BOB LEIKER
K981966 06/04/1998 NOSEBLEED NOSECLIP MICHAEL M. KNOTT, M.D. MICHAEL M KNOTT
K982006 06/08/1998 MICOMED - HALM ZIELKE INSTRUMENTATION MICOMED GMBH CHARMAINE HENDERSON
K982278 06/29/1998 MICRINS MICRO ANASTOMOSIS CLAMP MICRINS SURGICAL, INC. BERNHARD TEITZ
K981922 06/01/1998 LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI MICROAIRE SURGICAL INSTRUMENTS, INC. CARL ANGLES
K981976 06/01/1998 ACUTRON MENTOR MODEL 961 MICROCURRENT RESEARCH, INC. PAUL DAVIS
K982276 06/29/1998 BAHO AUTOCLAVABLE LAPAROSCOPE MICROPTIX INT'L, LLC. GEORGE N HALLACK
K982018 06/08/1998 LIGHT SABER ASPIRATION NEEDLE MINRAD, INC. JOHN MCNEIRNEY
K982420 06/15/1998 MITEK MICRO ANCHOR MITEK PRODUCTS EDWARD F KENT
K982173 06/19/1998 BUZBEE MWR ELECTRONICS INDUSTRIAL CO. MANFRED W ROSCHER
K982098 06/15/1998 "TUTODROP 1" AND "TUTODROP 2" MYCO MEDICAL SUPPLIES, INC. SANJIV KUMAR
K982082 06/15/1998 HANDISOL WOUND HEALING NATIONAL BIOLOGICAL CORP. FRANCIS D LAMM
K981958 06/04/1998 LEISEGANG VIDEO COLPOSCOPE NETOPTIX CORP. MARY MCNAMARA-CULLINANE
K982130 06/17/1998 RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201 NEW DEANTRONICS, LTD. LEWIS WARD
K981910 06/01/1998 SUCTION CATHETER NI-MED, INC. MICHAEL GIBLIN
K982277 06/29/1998 MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K981949 06/03/1998 NUMOBAG NUMOTECH, INC. W. PATRICK NOONAN
K981963 06/04/1998 SENSITEX EXAMINATION GLOVE OAK CAROLINA, INC. DARRELL ALFORD
K982244 06/25/1998 MAYFIELD ACCISS OPTICAL SYSTEM OHIO MEDICAL INSTRUMENT CO., INC. KENNETH MILLER
K982289 06/30/1998 HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K982035 06/10/1998 OLYMPUS CALCIUM ARSENAZO III REAGENT OLYMPUS DIAGNOSTICA GMBH LAURA STORMS-TYLER
K981917 06/01/1998 POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) OON CORP. RESOURCES CLEMENT K.K OON
K982110 06/16/1998 POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR OPTECH, INC. JAMES A BROOKS
K982061 06/04/1998 STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) ORASURE TECHNOLOGIES, INC. SAM R NIEDBALA
K982263 06/29/1998 MB/BACT BLOOD CULTURE BOTTLE ORGANON TEKNIKA CORP. REBECCA A RIVAS
K982088 06/15/1998 AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM ORTHO KINETICS CORP. STEVEN O LUSE
K982032 06/10/1998 OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS OSTEONICS CORP. KATE SUTTON
K982090 06/15/1998 PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM PACEART, INC. GEORGE MYERS
K981953 06/03/1998 VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS PARAGON TRADE BRANDS, INC. ROBERT J STAAB
K982050 06/11/1998 MODEL MS-2 HANDPIECE PARKELL, INC. NELSON GENDUSA
K982235 06/25/1998 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA DILLON
K982156 06/18/1998 PASCO MIC AND MIC/ID PANELS/ CEFDINIR PASCO LABORATORIES, INC. LINDA K DILLON
K982146 06/17/1998 PICTOOLS MEDICAL TOOL KIT MODEL 1.0 PEGASUS IMAGING CORP. ANDREW HUDSON
K981907 06/01/1998 V.F.I.-VISCOUS FLUID INFUSION TUBING SET PEREGRINE SURGICAL LTD. TODD RICHMOND
K982105 06/16/1998 ORAL POTENTIAL METER (OPM) PERTEC OF WISCONSIN, INC. DOUGLAS L COOK
K982152 06/18/1998 QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 PHAMATECH CARL A MONGIOVI
K982010 06/08/1998 FACTS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K981959 06/04/1998 OUTLOOK LARGE PHASED ARRAY NECK COIL PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K982203 06/22/1998 CAAS II LVA BIPLANE OPTION PIE MEDICAL EQUIPMENT B.V. FRANK ANIBA
K982128 06/17/1998 SHIKANI-FRENCH SPEAKING VALVE PILLING WECK SURGICAL ELIZABETH LAZARO
K981978 06/05/1998 AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR POINTE SCIENTIFIC, INC. WILLIAM F WALTERS, JR.
K982040 06/10/1998 MEDPOR SURGICAL GRANULE IMPLANTS POREX SURGICAL, INC. HOWARD MERCER
K982127 06/17/1998 POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER POROUS MEDIA CORP. KEITH A ROBERTS
K982062 06/15/1998 CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 PRECISION BIOLOGICALS, INC. SANDY MORRISON
K982281 06/30/1998 SERAQUEST RUBELLA IGM QUEST INTL., INC. ROBERT A CORT
K982231 06/25/1998 STATUSFLOW R & D SYSTEMS, INC. KENNETH T EDDS
K982182 06/22/1998 FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 RADI MEDICAL SYSTEMS AB MATS GRANLUND
K981973 06/05/1998 SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM RAM SCIENTIFIC GEOFFREY LEVITT
K982341 06/22/1998 DIRECT HDL-CHOLESTROL LIQUID RANDOX LABORATORIES, LTD. P ARMSTRONG
K982096 06/15/1998 DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO RAPID MFG. CO. CHARITY MARTIN
K982056 06/09/1998 RAICHEM CO2 REAGENT REAGENTS APPLICATIONS, INC.
K982115 06/16/1998 LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY RIM-WIDE COMPANIES, INC. DANIEL HSU
K981897 06/01/1998 ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K982087 06/15/1998 ROCHE CRP T CONTROL N ROCHE DIAGNOSTIC SYSTEMS, INC. RITA SMITH
K981931 06/02/1998 CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH PATRICIA M KLIMLEY
K982217 06/24/1998 AC/AD LINEARITY VERIFIERS SC CALIBRATORS & CONTROLS LLC. ROY F SCHALL, JR
K982136 06/17/1998 JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 SCHIFF & CO. ANNE M CESARIO
K982101 06/15/1998 SHELHIGH NO-REACT DURA SHIELD SHELHIGH, INC. SHLOMO GABBAY
K982193 06/22/1998 ESOPHAGEAL STETHOSCOPE SHORE MEDICAL, INC. MARK RICHARDSON
K981975 06/05/1998 LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED SIAM SEMPERMED CORP. LTD. DON MORRIS
K982028 06/09/1998 FLUOROSPOT COMPACT SIEMENS MEDICAL SOLUTIONS USA, INC. MALGORZATA STANEK
K982209 06/23/1998 ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 SIGMA DIAGNOSTICS, INC. WILLIAN R GILBERT
K982236 06/25/1998 SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K982251 06/26/1998 SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K982049 06/11/1998 BIOPSY M SITCO, INC. ROBERT H MCCARTHY
K982149 06/18/1998 SMITH & NEPHEW DYONICS MICROLAPAROSCOPE SMITH & NEPHEW, INC. DEBORAH J CONNORS
K982067 06/12/1998 MAGNETIC PORT SILICONE TISSUE EXPANDER SPECIALTY SURGICAL PRODUCTS, INC. T. JAN VARNER
K982258 06/26/1998 MAMMARY SIZER SPECIALTY SURGICAL PRODUCTS, INC. T JAN VARNER
K982065 06/12/1998 STERILE SILICONE EXTERNAL WOUND COVER SPECIALTY SURGICAL PRODUCTS, INC. T. JAN VARNER
K981902 06/01/1998 SPENCO SILICONE GEL SHEET SPENCO MEDICAL CORP. BRENDA HUNT
K982225 06/24/1998 SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 SPIRACLE TECHNOLOGY GUY GANSEL
K982099 06/15/1998 MOMENTUM NO. FS008 WHEELCHAIR SRIRAM ENTERPRISES D.B.A. MOMENTUM GROUP RON MOSETICH
K982188 06/22/1998 STERI-PAK BOWIE DICK TEST PACK STERITEC PRODUCTS MFG. CO., INC. LON BRUSO
K982014 06/08/1998 STOCKERT COMPACT SYSTEM STOECKERT INSTRUMENTE ROSINA ROBINSON
K982290 06/29/1998 CHEM-CHEX STAT (NEW) STRECK LABORATORIES, INC. PAUL KITTELSON
K982264 06/29/1998 FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 SURVIVALINK CORP. SEW-WAH TAY
K982148 06/18/1998 PRODIGY 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K982103 06/15/1998 ULMER (VNG) VIDEO NYSTAGMOGRAPH SYNAPSYS, INC. VERA BUFFALOE
K982212 06/23/1998 VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010 SYNERGETICS, INC. KURT GAMPP
K982222 06/24/1998 SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K981950 06/03/1998 SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 SYSMEX CORP. CATHERINE M TRESTER
K982117 06/16/1998 FLUID CONTROL T.A. COLEMAN ENT. KEITH A BARRITT
K982257 06/26/1998 VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD. CHIN-YU LIN
K982015 06/08/1998 VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE TAIAN PLASTICS PRODUCTS (JINGXING) CO., LTD. MR.LIN CHIN-YU
K981938 06/02/1998 TAMPA HYPERBARIC MONOPLACE CHAMBER TAMPA HYPERBARIC ENT. MICHAEL CAPRIA
K982223 06/24/1998 CAPIOX SX HARDSHELL RESEVOIR TERUMO MEDICAL CORP. SANDI HARTKA
K981912 06/01/1998 HUMAN IGA SUBCLASS BNII COMBI KIT THE BINDING SITE, LTD. JAY H GELLER
K982100 06/15/1998 IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS THE BINDING SITE, LTD. JAY H GELLER
K981915 06/01/1998 TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION THE BINDING SITE, LTD. JAY H GELLER
K981914 06/01/1998 TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION THE BINDING SITE, LTD. JAY H GELLER
K981997 06/08/1998 POSI-STOP/POSI-TRAC SYSTEM THE DENTAL MEDICAL DEVICE CO., L.L.C. MARCI BLOOM
K982133 06/17/1998 OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT THE OLYMPUS OPTICAL CO. RUTH C FORSTADT
K981993 06/08/1998 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K981923 06/01/1998 THE SNORE PEACE THE SNORE PEACE GROUP DAVID V SHEEHAN
K982150 06/18/1998 EL-ANA PROFILES: EL-ENA/4 THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K982622 06/18/1998 EL-ANA PROFILES: EL-ENA/5 THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K982112 06/16/1998 THERMATREK IRIS-3 INFRARED IMAGING SYSTEM THERMATREK, INC. DAVID R BALZER
K982265 06/29/1998 AQUILION CT SCANNER, MODEL TSX-101A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K982121 06/16/1998 ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT TRACE SCIENTIFIC LTD. DAVID JOHNSTON
K982120 06/16/1998 DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) TREX MEDICAL CORP. WILLIAM T COUSINS
K982179 06/22/1998 TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER TRUDELL MEDICAL DARRYL FISCHER
K982181 06/22/1998 TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER TRUDELL MEDICAL DARRYL FISCHER
K982228 06/25/1998 FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 TZ MEDICAL, INC. BYRON ZAHLER
K981908 06/01/1998 UM-150A UMECO UNION MEDICAL ENGINEERING ANNIE VELEZ
K982113 06/16/1998 UMECO OPTIMA 694 RUBY LASER SYSTEM UMECO, INC. IAIN D MILLER
K982611 06/26/1998 UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE) UNIJECT GLOVES PCL SARA JOHNSON
K981946 06/03/1998 CLEARVIEW IM UNIPATH LTD. LOUISE ROBERTS
K981935 06/02/1998 POLYSORB SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JAMIE YIEH
K982226 06/24/1998 UROMED BRACHYTHERAPHY IODINE-125 SOURCES UROMED CORP. FREDERICK TOBIA
K982140 06/17/1998 CLINICAL ELECTRONIC THERMOMETER VALEO CORP. PHIL ZULUETA
K981916 06/01/1998 LIGASURE VESSEL SEALING SYSTEM VALLEYLAB, INC. CHARLES COPPERBERG
K981944 06/03/1998 BREATHERITE VENTLAB CORP. E.J. SMITH
K981998 06/08/1998 PEDIATRIC INSTATRAK SYSTEM VISUALIZATION TECHNOLOGY, INC. MARY MCNAMARA-CULLINANE
K982016 06/08/1998 PIPER IPPB MODEL 2055 VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K982271 06/29/1998 WAKO DIRECT LDL-C WAKO CHEMICALS, USA, INC. TONYA MALLORY
K981937 06/02/1998 WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM WELCH ALLYN, INC. KATHY LOWTHER
K982097 06/15/1998 WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY LAMOUREUX
K982294 06/30/1998 XOMED SILICONE PRE-FORM BLOCKS XOMED, INC. ROY BERENS


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