FDA 510(k) Applications Received During September, 1999

FDA 510(k) Number Submission Date Device Name Applicant Contact
K993116 09/20/1999 A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER A & D ENGINEERING, INC. JERRY WANG
K993154 09/21/1999 LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM A.R.C. LASER CORP. DANIEL HOEFER
K992993 09/07/1999 ETEST FOR QUINUPRISTIN/DALFOPRISTIN AB BIODISK ANNE BOLMSTROM
K993211 09/24/1999 PICCOLO SODIUM TEST SYSTEM ABAXIS, INC. LISA MCGRATH
K993083 09/15/1999 ALCYON 300I (WITH ISE MODULE) ANALYZER ABBOTT LABORATORIES MARK LITTLEFIELD
K993065 09/13/1999 ACON COMBO PREGNANCY ACON LABORATORIES, INC. JIXUN LIN
K993203 09/24/1999 ACON ONE STEP PREGNANCY TEST STRIP (URINE) ACON LABORATORIES, INC. NORA C.R. YORK
K992946 09/01/1999 RENEW RECEIVER ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K993248 09/28/1999 AMPLATZER SIZING BALLOON AGA MEDICAL CORP. JODI L LOCHER
K992995 09/07/1999 AROMATIC AND FLAVORED TONGUE DEPRESSOR AGA PLASTIC IND. COM. LTDA. SUSAN D GOLDSTEIN-FALK
K993276 09/30/1999 SIMPLIFY D-DIMER, MODEL DCGK1 AGEN BIOMEDICAL LTD. RUSSEL RICHARDS
K993245 09/28/1999 CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM ALBA CRITICAL CARE LTD TED VANDER WIEDE
K992951 09/01/1999 CONVERTORS SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K993278 09/30/1999 AMBU NEONATE SILICONE RESUSCITATOR AMBU, INC. SANJAY PARIKH
K993151 09/21/1999 RADID DRUG SCREEN 5-PANEL TEST AMERICAN BIO MEDICA CORP. JOHN B DUBECK
K993184 09/23/1999 R1000 SERIES INSULIN PUMP ANIMAS CORP. MONICA FERRANTE
K992953 09/01/1999 SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM ANSELL PERRY JAMES R CHATTERTON
K993135 09/20/1999 IMPLANTABLE CLIP FOR GENERAL SURGERY APPLIED MEDICAL RESOURCES ANIL BHALANI
K993283 09/30/1999 OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C ARNOLD & RICHTER CINE TECHNIK THOMAS POPP
K992972 09/03/1999 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000 ARTHROCARE CORP. BETTY M JOHNSON
K992958 09/02/1999 ADVANTA GRAFT (<6MM) ATRIUM MEDICAL CORP. KAREN HALL
K992960 09/02/1999 ADVANTA GRAFT (>6MM) ATRIUM MEDICAL CORP. KAREN HALL
K992991 09/07/1999 ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT ATRIUM MEDICAL CORP. KAREN HALL
K992998 09/07/1999 AUTOMATED OPHTHALMICS SOFTIPS AUTOMATED OPHTHALMICS, INC. NORMAN BICKMAN
K993024 09/09/1999 CELSITE IMPLANTABLE PORT WITH VALVED CATHETER B. BRAUN OF AMERICA, INC. MARK S ALSBERGE
K993138 09/20/1999 BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT BALLARD MEDICAL PRODUCTS E. MARTIN CHAMBERLAIN
K993039 09/10/1999 VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) BAUSCH & LOMB, INC. VANADA JOHNSON
K993120 09/20/1999 MODIFIED BLOOD RECIPIENT SET BAXTER HEALTHCARE CORP. JUDY KANNENBERG
K993186 09/22/1999 SYNERCID, 15 UG, BBL SENSI-DISC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BRADFORD M SPRING
K993210 09/24/1999 ACCESS HYBRITECH FREE PSA QC, MODEL 37219 BECKMAN COULTER, INC. MICHEL GUST
K993022 09/09/1999 SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS BECKMAN COULTER, INC. GAIL LEFEBVRE
K993023 09/09/1999 SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS BECKMAN COULTER, INC. GAIL L EFEBVRE
K993107 09/17/1999 BIO-RAD HOMOCYSTEINE BY HPLC BIO-RAD Patricia M Klimley
K993238 09/27/1999 FORTOSS-CEMA BIOCOMPOSITES LTD. JS BRATT
K993033 09/09/1999 INTRAY GC BIOMED DIAGNOSTICS, INC. ROBERT D HALL
K993111 09/17/1999 ASCENT KNEE SYSTEM BIOMET MANUFACTURING, INC. MARY VERSTYNEN
K993159 09/21/1999 MAXIM KNEE SYSTEM BIOMET, INC. TRACY J BICKEL
K993025 09/09/1999 MODIFICATION TO BONE MULCH SCREW SYSTEM BIOMET, INC. FRED MCCLURE
K992947 09/01/1999 CANNULATED SMARTSCREW MODELS 224540C, 224570C BIONX IMPLANTS, LTD. TUIJA ANNALA
K993074 09/14/1999 SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 BIONX IMPLANTS, LTD. TUIJA ANNALA
K993073 09/14/1999 SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 BIONX IMPLANTS, LTD. TUIJA ANNALA
K992968 09/03/1999 CARTO EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. SANDRA WILLIAMSON
K993118 09/20/1999 BIOTEQUE A.V. FISTULA NEEDLE SET BIOTEQUE CORP. ALLEN REICH
K993139 09/20/1999 YP 45/15-BP; YP 53/15-BP; YP 60/15-BP BIOTRONIK, INC. Jon Brumbaugh
K993225 09/27/1999 BLADEWORKS MICROKERATOME BLADE BLADE WORKS, INC. GARY S MOCNIK
K993115 09/20/1999 MULTITAK SS BONUTTI RESEARCH, INC. PATRICK BALSMANN
K993232 09/27/1999 WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC. RONALD W BENNETT
K993000 09/07/1999 BARD HYDROPHILIC COATED GUIDE WIRES C.R. BARD, INC. DEBORAH L HERRINGTON
K993014 09/08/1999 MODIFICATION TO DOCUMENT THYROID CAL.VER CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) KAREN HICKEY
K993002 09/07/1999 CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 CERAMOPTEC, INC. CAROL J MORELLO
K993001 09/07/1999 COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED COBE CARDIOVASCULAR, INC. LYNN LEONARD
K993085 09/15/1999 AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA COGENT DIAGNOTICS LTD. RANDY WILSON
K993086 09/15/1999 AUTOSTAT II ANTI-GLIADIN IGA ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K993087 09/15/1999 AUTOSTAT II ANTI-GLIADIN IGG ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K993255 09/28/1999 BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE COLTENE/WHALEDENT INC. H.J. VOGELSTEIN
K993140 09/20/1999 WATER FOR TISSUE CULTURE, MODELS 1500 CONCEPTION TECHNOLOGIES GREG HOLLAND
K993252 09/28/1999 METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP COOPERVISION, INC. BONNIE TSYMBAL
K993161 09/22/1999 COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM COPAN DIAGNOSTICS, INC. MARY MCNAMARA-CULLINANE
K993091 09/16/1999 PALMAZ XL TANSHEPATIC BILIARY STENTS CORDIS CORP. ARIEL MACTAVISH
K993266 09/30/1999 PROWLER PLUS INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K992965 09/02/1999 CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 CORDIS WEBSTER, INC. MARY ADAMS
K992957 09/02/1999 ADVANCED D-DIMER DADE BEHRING, INC. REBECCA S AYASH
K992959 09/02/1999 BEHRING COAGULATION SYSTEM (BCS) DADE BEHRING, INC. REBECCA S AYASH
K993273 09/30/1999 N LATEX FERRITIN DADE BEHRING, INC. REBECCA S AYASH
K993174 09/22/1999 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 DADE BEHRING, INC. REDAMES RIESGO
K993102 09/16/1999 DRIED GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. TREVOR WALL
K993098 09/16/1999 HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 DATA MEDICAL ASSOCIATES, INC. THOMAS G DOLLAR
K992956 09/02/1999 LUCITONE FRS FLEXIBEL DENTAL RESIN DENTSPLY INTL. P. JEFFERY LEHN
K993099 09/16/1999 BREMER HALO SYSTEM TITANIUM SKULL PIN DEPUY ACROMED FRANK MASS
K993030 09/07/1999 MODIFICATION TO ISOLA SPINAL SYSTEM DEPUY ACROMED FRANK MAAS
K993089 09/16/1999 DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER DEROYAL CARDIOVASCULAR, INC. LOIS MARSH
K993178 09/23/1999 UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K993254 09/28/1999 IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K993251 09/28/1999 IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K993129 09/20/1999 UCLA/UNIVERSAL ABUTMENT DIAMODENT JEFF RASSOLI
K992999 09/07/1999 DAISY PROTECTED SCALP VEIN SET DIASOL, INC. MONICA ABELES
K993212 09/24/1999 DRYASOL ACID CONCENTRATE MIX DIASOL, INC. MONICA ABELES
K993187 09/23/1999 SHELLY PROTECTED AV FISTULA NEEDLE DIASOL, INC. MONICA ABELES
K993224 09/27/1999 T-GEAR, MODEL TG/400-700 DONTECH PRODUCTS B.V. JAN JORENS
K993146 09/20/1999 DORNIER SCANNER HANDPIECE DORNIER SURGICAL PRODUCTS, INC. CAROL WERNECKE
K992949 09/01/1999 SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST DRUG DETECTION DEVICES, LTD. BRUCE CHRISTIE
K993119 09/20/1999 STERILE HYDROGEL DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SAM LAKHANI
K992996 09/07/1999 ENABLE ENDOSCOPIC BIPOLAR SCISSORS ENABLE MEDICAL CORP. MARK L FRIEDMAN
K993010 09/07/1999 BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER ENVIRONMENTAL TECTONICS CORP. HOWARD M HOLSTEIN
K992966 09/02/1999 REFERENCE ESPE DENTAL AG ANDREAS PETERMANN
K993054 09/13/1999 ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 ETHICON ENDO-SURGERY, INC. RUTH ANN WOOD
K993082 09/15/1999 EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT EXACTECH, INC. GARY J MILLER
K993199 09/23/1999 POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER FERRARIS MEDICAL, INC. JONATHAN S KAHAN
K993046 09/10/1999 FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 FIBRA SONICS, INC. ROBERT BROHM
K993095 09/16/1999 FRIALIT-2 SELECT COMPONENTS FRIADENT GMBH CAROL PATTERSON
K993064 09/13/1999 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) GAMBRO RENAL CARE PRODUCTS WILLIAM M TOWNSEND
K993037 09/09/1999 LCV+ VERSION 2 GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K993090 09/16/1999 SILHOUETTE FC GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K993202 09/24/1999 EIM-107 PREP-CHECK GENERAL DEVICES MICHAEL SMITH
K993069 09/13/1999 GE DIASONICS GATEWAY AND GATEWAY FX GENERAL ELECTRIC CO. ALLEN SCHUH
K993132 09/20/1999 GENZYME DIRECT AMYLASE VERIFIER GENZYME CORP. BARBARA PIZZA
K993242 09/27/1999 CASTLE SURGICAL LIGHT, MODEL 3000 GETINGE/CASTLE, INC. PETER L KOSTE
K993127 09/20/1999 MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE) GLOVESWORLD INDUSTRIES SDN. BHD. BIEN LONG NIEN
K992994 09/07/1999 TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; GYRUS ENT L.L.C. JEFF COBB
K992970 09/03/1999 DIGIT WIDGET HAND BIOMECHANICS LAB, INC. JOHN M AGEE
K993128 09/20/1999 HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] HEALTH HERO NETWORK, INC. JOE SCHWOEBEL
K992971 09/03/1999 REP CHOLESTEROL PROFILE KIT HELENA LABORATORIES ERIC PETERSON
K992985 09/03/1999 GLUMA COMFORT BOND HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K992977 09/03/1999 HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A HEWLETT-PACKARD CO. WARREN R WALTERS
K993171 09/21/1999 HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A HEWLETT-PACKARD CO. DAVE OSBORN
K993169 09/22/1999 MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A HEWLETT-PACKARD CO. SHEILA W PICKERING, PHD.
K993051 09/13/1999 VERSALET 7700 CARE CENTER, MODEL # 7700 HILL-ROM AIR-SHIELDS JAMES G CARPENTER
K992988 09/03/1999 PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM HOME DIAGNOSTICS, INC. KAREN DEVINCENT
K993004 09/07/1999 ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K993181 09/23/1999 HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K993077 09/14/1999 HOWMEDICA OSTEONICS RESTORATION HA HIP STEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K993009 09/07/1999 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY HYDROCISION, INC. DEBBIE IAMPIETRO
K993282 09/30/1999 IPI HUMIDIFIER CHAMBER I.P.I. MEDICAL PRODUCTS MAZH SAID, PH.D
K992955 09/01/1999 XPLORER 1000 IMAGING DYNAMICS CORP. ROBIN WINSOR
K992983 09/03/1999 BAHO AUTOCLAVABLE CYSTOSCOPE INNOVATIVE ENDOSCOPY COMPONENTS, LLC. GERALD GOIGITZER
K993222 09/27/1999 INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE INNOVATIVE GLOVES CO; LTD RAJEEV KUMAR SOOD
K993221 09/27/1999 INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED INNOVATIVE GLOVES CO; LTD RAJEEV KUMAR SOOD
K992964 09/02/1999 IBC VENT VALVE, MODEL 1400 INTERNATIONAL BIOPHYSICS CORP. H. DAVID SHOCKLET, JR
K992963 09/02/1999 I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401 INTERNATIONAL ISOTOPES, INC. REBECCA ELLIS
K993153 09/21/1999 INTRALASE 600C LASER KERATOME INTRALASE CORP. CHARLINE GAUTHIER
K993200 09/24/1999 MD 420/440/460/470/480/490 ISOPURE CORP. KEVIN C GILLESPIE
K993136 09/20/1999 JEL BIOS 10 (CODE NAME RD-1801) J.F. JELENKO & CO., INC. TRIDIB R DASGUPTA
K993152 09/21/1999 JEL BIOS 18 (CODE NAME RD- 1214) J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K993247 09/28/1999 NITRILE POWDER FREE PATIENT EXAMINATION GLOVES JDA INTL., INC. KEIDY GU
K993173 09/22/1999 GOLD CORE 55 JENERIC/PENTRON, INC. ANNMARIE TENERO
K993175 09/22/1999 GOLD CORE 75 JENERIC/PENTRON, INC. ANNMARIE TENERO
K993249 09/28/1999 OPC LOW WEAR OPAQUE PORCELAIN JENERIC/PENTRON, INC. ANNMARIE TENERO
K993229 09/27/1999 ANALGESIC PULSER, MODEL AP-439 JOHARI ELECTRO-TECH CO. NISHA JOHARI
K993213 09/24/1999 K-ASSAY IGA KAMIYA BIOMEDICAL CO. COLIN GETTY
K993281 09/30/1999 K-ASSAY IGG KAMIYA BIOMEDICAL CO. COLIN GETTY
K992976 09/03/1999 K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR KAMIYA BIOMEDICAL CO. COLIN GETTY
K992954 09/01/1999 KEELER CRYO MASTER & PROBES KEELER INSTRUMENTS, INC. EUGENE R VAN ARSDALE
K993124 09/20/1999 DISPODRILL KIS PRODUCTS REUBEN HERTZ
K993182 09/23/1999 DISPOPROPHY KIS PRODUCTS REUBEN HERTZ
K993284 09/30/1999 QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. WAYNE WITBECK
K993268 09/30/1999 MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT MALLINCKRODT DAR S.R.L. GIUSEPPE TOMASINI
K993094 09/16/1999 AERO-CLICK MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH TORSTEN SCHLICHTHOLZ
K993008 09/07/1999 QUANTITATIVE SENTINEL SYSTEM MARQUETTE MEDICAL SYSTEMS, INC. MARIA VITUG FOUTS
K993034 09/09/1999 MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD MEDICA, INC. RHODORA CHAPOCO
K993122 09/20/1999 MSP M/K BLADE MEDICAL STERILE PRODUCTS, INC. GARY C DIONNE
K993149 09/21/1999 PERITONEAL DIALYSIS CATHETERS AND ADAPTERS MEDIONICS INTERNATIONAL, INC. MASHESH AGARWAL
K993223 09/27/1999 RAPICURE 200 (CURING AND WHITENING LIGHT) MEDIPHOTONIX, LC ROBERT MCCLANE
K993042 09/10/1999 MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT MEDIVATORS, INC. NORMAN MINER
K993170 09/22/1999 MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. BETTY A LOCK
K993080 09/14/1999 AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE MEDTEXX PARTNERS, INC. E. J SMITH
K993145 09/20/1999 MEDTRONIC AVE BRIDGE STENT MEDTRONIC AVE, INC. SUSAN WALTON
K993012 09/08/1999 MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 MEDTRONIC MINIMED JENNIFER LYONS
K993226 09/27/1999 MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 MEMCATH TECHNOLOGIES LLC. MARC JAKER
K993057 09/13/1999 MBA MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K992997 09/07/1999 OSTEOMARK NTX POC METRIKA, INC. Erika B Ammirati
K993257 09/29/1999 .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K993234 09/27/1999 MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS MICROMEDICS, INC. CHARLES GROTE
K993013 09/07/1999 SURE BOND MIRADENT DISTRIBUTING CO., LLC. BERNARD SESSMAN
K993261 09/29/1999 TALON ANCHOR SNAP-PAK MITEK PRODUCTS PAULA A BULGER
K993233 09/27/1999 OBC-085 BREAST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K993279 09/30/1999 QSC-085 SHOULDER ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K993235 09/27/1999 QWH-085 WRIST ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K993130 09/20/1999 ULTRA-GARMENT ELECTRODE NEWWAVE MEDICAL LLC. ROBERT ARMSTRONG
K993176 09/22/1999 MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY NORLAND MEDICAL SYSTEMS, INC. TERRY SCHWALENBERG
K993104 09/16/1999 STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR NOVA BIOMEDICAL CORP. PAUL W MAC DONALD
K992980 09/03/1999 ENGAGE JAW INSERTS NOVARE SURGICAL SYSTEMS, INC. NOEL MESSENGER
K993062 09/13/1999 CHEST DRAINAGE TUBING OLSON MEDICAL SALES, INC. GARRY A COURTNEY
K993060 09/13/1999 GAS FILTER OLSON MEDICAL SALES, INC. GARRY A COURTNEY
K993050 09/10/1999 OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED OMNIGRACE LTD. WILLIAM E PATTON
K993208 09/24/1999 STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K993068 09/13/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS MARLENE SHULMAN
K993093 09/16/1999 HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) PAMITEX INDUSTRIES SDN BHD SAID AWANG
K993201 09/24/1999 HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES PAMITEX INDUSTRIES SDN BHD SAID AWANG
K993097 09/16/1999 HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM PAMITEX INDUSTRIES SDN BHD SAID AWANG
K993183 09/23/1999 POWDER FREE GLOVES (POLYMER COATED) PAN-CENTURY RUBBER PRODUCTS SDN. BHD. H.R.K MURTHY
K993141 09/21/1999 AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 PHAMATECH CARL A MONGIOVI
K993165 09/22/1999 QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 PHAMATECH CARL A MONGIOVI
K993109 09/17/1999 VARELISA RECOMBI ANA PROFILE PHARMACIA & UPJOHN CO. KAREN E MATIS
K993108 09/17/1999 VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 PHARMACIA & UPJOHN CO. KAREN E MATIS
K993227 09/27/1999 PHILIPS INTURIS DICOM RECORDER PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K993188 09/23/1999 ENDOSTEPPER 1 PHYTRON- ELEKTRONIK GMBH CORNELIUS RIESS
K993377 09/28/1999 MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K993285 09/30/1999 AURORA SL PREMIER LASER SYSTEMS, INC. BETH A ROBERTS
K993131 09/20/1999 NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY PRIMUS, INC. JIMMIE K NOFFSINGER
K993280 09/30/1999 PROSTEC 125I BRACHYTHERAPY SEEDS PROSTEC LLC. AL WEISENBORN
K992950 09/01/1999 CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS PROSTHETIC SOFT LENS CORP. WILLIAM HOFFMAN
K993058 09/13/1999 PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL PURE WATER, INC. RHONDA S MCCOY
K993272 09/30/1999 PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM PURE WATER, INC. CYNTHIA P WALTERS
K993088 09/16/1999 PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI PURITAN BENNETT CORP. TONY KEAVENEY
K993220 09/27/1999 PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM PURITAN BENNETT CORP. TONY KEAVENEY
K993071 09/14/1999 PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 PURITAN BENNETT CORP. DELTON WEST
K993271 09/30/1999 QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS QUALITY LATEX CORP. SDN BHD SHARENE WAN
K993100 09/16/1999 REDI-SCREEN REDWOOD BIOTECH, INC. JANIS FREESTONE
K992969 09/03/1999 RESPIRONICS TOTAL FACE MASK RESPIRONICS, INC. DAVID J VANELLA
K993103 09/16/1999 ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARA
K992981 09/03/1999 ELECSYS ESTRADIOL CALSET II ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K993048 09/10/1999 ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST ROCHE DIAGNOSTICS CORP. LUANN OCHS
K993063 09/13/1999 RUSCH BRILLANT SILICONE FOLEY RUSCH INTL. JULIE A BEAUMONT
K993194 09/23/1999 RUSCH MANUAL RESUSCITATOR BAG RUSCH, INC. RONALD YOUNG
K993117 09/20/1999 SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG SAFESKIN CORP. EUGENE V GOORCHENKO
K993125 09/20/1999 SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM SAFETY MEDICAL SUPPLY INT,., INC. YOVETTE MUMFORD
K992986 09/03/1999 SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER SALTER LABS DUANE KAZAL
K993134 09/20/1999 CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) SEAL POLYMER INDUSTRIES BHD. CHAN CHIN HONG
K993133 09/20/1999 CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN SEAL POLYMER INDUSTRIES BHD. CHAN CHIN HONG
K993167 09/22/1999 MILLENNIUM INFANT VENTILATOR SECHRIST INDUSTRIES, INC. GREG GODFREY
K993081 09/15/1999 IO-DRIVE SELECTIVE MED COMPONENTS, INC. RICK FISHER
K993049 09/10/1999 DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K992979 09/03/1999 SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. JULIA WU
K993017 09/08/1999 PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE SHIN CHANG MEDICAL CO., LTD. JAN J FRANK
K993240 09/27/1999 SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
K993231 09/27/1999 SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
K993269 09/30/1999 IQ NASAL MASK, MODEL P/N 50160 SLEEPNET CORPORATION PAUL R CHIESA
K992945 09/01/1999 RCI FIXATION SCREWS (WITH ASSORTED SIZES) SMITH & NEPHEW, INC. NICHOLAS CONDAKES
K993106 09/17/1999 SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) SMITH & NEPHEW, INC. JANET JOJNSON GREEN
K993142 09/21/1999 ELITE CUSTOM SOMA BLUE, INC. JOHN M MITCHELL
K993143 09/21/1999 VITALITY SYSTEM SOMA BLUE, INC. JOHN M MITCHELL
K993092 09/16/1999 SONADA ULTRASOUND SYSTEM SONOVISION CORP. PAUL SCHNEIDER
K993265 09/29/1999 SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 SORING GMBH MEDIZINTECHNIK CARL ALLETTO
K993027 09/09/1999 ESKA MODULAR HIP SYSTEM SPECS USA, INC. THOMAS P MONKUS
K993126 09/20/1999 CD-CHEX CD 34 STRECK LABORATORIES, INC. HAL SORNSON
K993239 09/27/1999 STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX STRYKER CORP. NICOLE PETTY
K993045 09/10/1999 BARIATRIC LAPAROSCOPE, MODEL 367 Stryker Endoscopy ROBERT H DAHLA
K993166 09/22/1999 STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM Stryker Endoscopy TODD MILLER
K993061 09/13/1999 STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM STRYKER INSTRUMENTS KRISTEN R KELLEY
K993148 09/21/1999 STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA STRYKER INSTRUMENTS SUZANNE VELAZQUEZ
K993259 09/29/1999 INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K993043 09/10/1999 MS-30 FEMORAL STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K993067 09/13/1999 SILHOUETTE SPINAL FIXATION SYSTEM SULZER SPINE-TECH JANELL A COLLEY
K993258 09/29/1999 SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES SUPERMAX SDN BHD STANLEY THAI
K993190 09/23/1999 ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) SURGICAL INSTRUMENT SYSTEMS (SIS), LTD Judy Gordon
K993021 09/08/1999 METRX SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
K992978 09/03/1999 RICROKERATOME BLADE SURGISTAR, INC. JONATHAN WOODWARD
K993072 09/14/1999 SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) SURVIVALINK CORP. Sew-Wah Tay
K992990 09/07/1999 QUICKPAC II ONE STEP COCAINE TEST SYNTRON BIORESEARCH, INC. CLEVE W LAIRD
K993026 09/09/1999 ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS SYVA CO. PAUL L ROGERS JR.
K993028 09/09/1999 ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 SYVA CO. PAUL L ROGERS
K993031 09/09/1999 ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 SYVA CO. PAUL L ROGERS
K993029 09/09/1999 ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 SYVA CO. PAUL L ROGERS
K993160 09/21/1999 OMEGA TRAC, MODEL Z100 TEFTEC CORP. THOMAS E FINCH, III
K993189 09/23/1999 CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING TERUMO CORP. GARRY A COURTNEY
K993191 09/23/1999 TFX MEDICAL INTRODUCER ASSEMBLY TFX MEDICAL, INC. JULIA A BEAUMONT
K993101 09/16/1999 LITEAIRE THAYER MEDICAL CORP. DAVID T SLADEK
K993147 09/21/1999 DECAP THE KIPP GROUP GARY WERSCHMIDT
K993041 09/10/1999 OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT THE OLYMPUS OPTICAL CO. ROBERT SHIFF
K993209 09/24/1999 SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY THERMOLASE CORP. GERALD FELDMAN, MPH, MBA
K992992 09/07/1999 AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DIANA THORSON
K993038 09/10/1999 TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. DIANA THORSON
K993205 09/24/1999 BOOKER BOX, MODEL PAD 5010 TZ MEDICAL, INC. BYRON KAHLER
K993123 09/20/1999 QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B UNITED PACIFIC CO., LTD. DANIEL YE HUA
K993055 09/13/1999 DEXIDE BIPOLAR FORCEPS II** DEVICE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHRISTOPHER A GRAHAM
K993019 09/08/1999 PACIFIC SURGICAL PATTIES V. MUELLER NEURO/SPINE TERRY JOHNSTON
K993052 09/13/1999 VYGON 2 FR EPICUTANEO PUR-CATHETER VYGON CORP. ROBERT SCHIFF
K993219 09/27/1999 WAKO BILIRUBIN CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K993162 09/22/1999 WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR WAKO CHEMICALS, USA, INC. TONYA MALLORY
K992952 09/01/1999 LORENZ DISTRACTION SYSTEM WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K992961 09/02/1999 LORENZ SMALL FRAGMENT SYSTEM WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K993157 09/21/1999 HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 WECK CLOSURE SYSTEMS BRIAN YOUNG
K993214 09/24/1999 DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) WRP SPECIALTY PRODUCTS SDN. BHD. OOI SOO KANG
K993215 09/24/1999 DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE WRP SPECIALTY PRODUCTS SDN. BHD. OOI SOO KANG
K993112 09/17/1999 XOMED ENT RF SYSTEM XOMED, INC. MARTIN D SARGENT
K993250 09/28/1999 THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K993036 09/09/1999 ZOLL M SERIES ETCO2 OPTION ZOLL MEDICAL CORP. PAUL DIAS


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