FDA 510(k) Decisions During April, 1999  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K990776 04/29/1999 AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM AAP IMPLANTATE AG ELLEN HENKE-KNUPP
K990722 04/22/1999 ETEST FOR CEFUROXIME AB BIODISK ANNE BOLMSTROM
K990845 04/13/1999 MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 ADVANCED SPINE FIXATION SYSTEMS, INC. GREG HOLLAND
K991223 04/30/1999 ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AESCULAP, INC. STEVE REITZLER
K991034 04/16/1999 CONVERTORS SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K990427 04/23/1999 ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K990486 04/23/1999 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K990485 04/23/1999 NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K990010 04/15/1999 ALTHIN MEDICAL AB ALTRACART II ALTHIN MEDICAL AB ULF LUNDGREN
K982722 04/12/1999 AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD AMBU, INC. SANJAY PARIKH
K982029 04/06/1999 SHARPS COLLECTION CONTAINER - SAF-T-SHELL AMERICAN MEDICAL MFG., INC. MIKE HOFTMAN
K990312 04/22/1999 AVIA PAIN MEDICATION DELIVERY SYSTEM AMTEC MEDICAL TERRELL L FRIEDRICH
K990775 04/21/1999 URETERAL ACCESS SHEATH SET APPLIED MEDICAL RESOURCES ANIL BHALANI
K990361 04/14/1999 HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU ARTHREX, INC. VERNON C BROWN
K990596 04/29/1999 DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K990422 04/27/1999 RENU MULTIPLUS MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K984059 04/09/1999 ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC CHARLES J WELLE
K990587 04/07/1999 ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 BIO-RAD ELIZABETH PLATT
K990610 04/27/1999 ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 BIO-RAD ELIZABETH PLATT
K990928 04/16/1999 LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 BIO-RAD ELIZABETH PLATT
K990858 04/21/1999 LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 BIO-RAD ELIZABETH PLATT
K990827 04/09/1999 MICROPLATE NEONATAL GALT ASSAY BIO-RAD JULIET CARRARA
K990888 04/07/1999 MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 BIO-RAD ELIZABETH PLATT
K990277 04/09/1999 O-RING ABUTMENT BIOHORIZONS IMPLANT SYSTEMS, INC. DIANA M EASTON
K983036 04/30/1999 SINGLE AXLE TOTAL ELBOW BIOMET, INC. FRED MCCLURE
K990821 04/29/1999 PROVIDENCE CUP SYSTEM BIOPRO, INC. CHERYL WARSINSKE
K990360 04/30/1999 AU6 BIOSOUND ESAOTE, INC. COLLEEN HIITLE
K982132 04/15/1999 BLEASE 6200 ANAESTHESIA VENTILATOR BLEASE MEDICAL EQUIPMENT LTD. FRANCIS X CASEY
K982137 04/09/1999 BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE BLEASE MEDICAL EQUIPMENT LTD. FRANCIS X CASEY
K990540 04/09/1999 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K990539 04/09/1999 BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K990542 04/09/1999 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K990541 04/09/1999 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K990543 04/09/1999 BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K990584 04/23/1999 GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE BROADLINE MEDICAL INDUSTRIES ANNA M RAMZA
K982696 04/01/1999 INTERPLANT BURDETTE MEDICAL SYSTEMS, INC. EVERETTE C BURDETTE
K990670 04/02/1999 HELIOFORM GOLD-BASED ALLOY C. HAFNER GMBH & CO. JOHN F LEMKER
K983102 04/12/1999 CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 CAMBRIDGE HEART, INC. JOHN D GREENBAUM
K990757 04/21/1999 CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA CANTOR & SILVER LTD. MARTIN DALSING
K984213 04/14/1999 NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS CAPITAL MARKETING TECHNOLOGIES, INC. JOHN SNYDER
K990439 04/19/1999 CARESIDE CK CARESIDE, INC. KENNETH B ASARCH
K990434 04/19/1999 CARESIDE CKMB CARESIDE, INC. KENNETH B ASARCH
K984223 04/28/1999 BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 CITIZEN WATCH CO., LTD. JOSEPH D EDMONDSON JR
K982053 04/20/1999 EEG ELECTRODES MODEL "445 SERIES" CLASS A ENT. JANICE A AUDI
K990711 04/13/1999 CODAN CHEMOSPIKE CODAN US CORP. FERGIE FERGUSON
K990798 04/28/1999 AUTOSTAT II ANTI-JO-1 ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K990796 04/28/1999 AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K990797 04/28/1999 AUTOSTAT II ANTI-SCL-70 ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K990625 04/28/1999 AUTOSTAT II ANTI-SM ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K990624 04/28/1999 AUTOSTAT II ANTI-SM/RNP ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K990627 04/28/1999 AUTOSTAT II ANTI-SS-A/RO ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K990626 04/28/1999 AUTOSTAT II ANTI-SS-B/LA ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K981535 04/02/1999 FOCUS PILOT CONTOURING WORKSTATION COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K990895 04/14/1999 OXYCON LENS CONCISE CONTACT LENS CO. DANIEL J MANELLI
K990726 04/02/1999 ENVY GUIDING CATHETER COOK, INC. APRIL LAVENDER
K990631 04/30/1999 CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC CORDIS CORP. CHARLES J RYAN
K990352 04/01/1999 COULTER AC T DIFF 2 ANALYZER COULTER CORP. THOMAS J ENGLISH
K990327 04/26/1999 RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS COULTER CORP. MARION S GAIDE
K990172 04/13/1999 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA COULTER CORP. MARION S GAIDE
K990825 04/16/1999 REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE DADE BEHRING, INC. LORRAINE PIESTRAK
K990824 04/16/1999 REVISED C-REACTIVE PROTEIN CALIBRATOR DADE BEHRING, INC. LORRAINE PIESTRAK
K983711 04/27/1999 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K990782 04/28/1999 DAUM NEUROGATE TROCAR DAUM GMBH E.J. SMITH
K982853 04/30/1999 SILK SUTURE DAVIS & GECK, INC. VANADA JOHNSON
K983680 04/28/1999 TRINITY II SINGLE CHAMBER DVT PUMP DELPHI CONSULTING GROUP J. HARVEY KNAUSS
K990356 04/29/1999 THE BAGNOLI-8 EMG SYSTEM DELSYS, INC. GIANLUCA DE LUCA
K991135 04/29/1999 SOFT TISSUE SUTURE WASHER DEPUY, INC. JANET G JOHNSON
K983467 04/02/1999 THERAPEP DHD HEALTHCARE CORP. JEAN WALLACE
K990754 04/20/1999 CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K990886 04/06/1999 IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K991277 04/27/1999 MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K982708 04/02/1999 SPQ TEST SYSTEM DIASORIN, INC. JUDITH J SMITH
K990248 04/16/1999 DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION DICOMIT IMAGING SYSTEMS CORP. TERRY CALLAHAN
K990332 04/14/1999 DUMEX IODOFORM PACKING STRIP DUMEX MEDICAL SURGICAL PRODUCTS, LTD. SHARMINI ATHERAY
K990159 04/19/1999 DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 DYNAMIC TECHNOLOGY CORP. YAW C YANG
K982134 04/14/1999 DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 DYNAMIC TECHNOLOGY CORP. YAW C YANG
K991130 04/20/1999 FLEXPLUG EAGLE VISION, INC. JIM BARLEY
K984337 04/09/1999 ELASTYLON POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. STEPHEN L THOMPSON
K990303 04/29/1999 EBI OMEGA 21 SYSTEM ELECTRO-BIOLOGY, INC. JON CAPAROTTA
K991092 04/29/1999 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM ELECTRO-BIOLOGY, INC. JONAS WILF
K990459 04/23/1999 EBI VUECATH ENDOSCOPIC SYSTEN ELECTRO-BIOLOGY, INC. JON CAPAROTTA
K990999 04/14/1999 MODIFICATION OF: EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. JONAS WILF
K990813 04/12/1999 REHCOR ELECTROMED CORP. DANIEL KAMM
K990759 04/15/1999 VIEW COM ELECTROMED INTL., LTD. PASCAL M KAUFMANN
K983456 04/21/1999 ENSITE 3000 SYSTEM ENDOCARDIAL SOLUTIONS, INC. ANDREW BALO
K982418 04/29/1999 BUECHEL-PAPPAS MODULAR SALVAGE STEM ENDOTEC, INC. GEORGE MAKRIS
K983919 04/07/1999 EMS MOUTH TO MASK RESUSCITATORS ENGINEERED MEDICAL SYSTEMS JEFF QUINN
K983997 04/02/1999 STERICHEK TOTAL CHLORINE TEST KIT ENVIRONMENTAL TEST SYSTEMS, INC. BRUCE G PIEKARSKI
K990082 04/09/1999 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 EPIC MEDICAL EQUIPMENT SERVICES, INC. JEFFREY SECUNDA
K990982 04/23/1999 CAVIT LC ESPE DENTAL AG ANDREAS PETERMANN
K990028 04/01/1999 ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE ETHICON ENDO-SURGERY, INC. CHUCK TABRI
K983776 04/26/1999 EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP EVENFLO CO., INC. DONALD E SEGAL
K990091 04/04/1999 S.P.A.R STERILE AMBULATORY RESERVOIR FAULDING PHARMACEUTICAL CO. HEIKE MAASER
K990906 04/29/1999 FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER FERRIS MFG. CORP. THEODORE R THORSON
K990174 04/01/1999 ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV FISMA, INC. TRACY S BEST
K990501 04/02/1999 POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM FLEXITECH SDN. BHD. TU AH KIM
K990495 04/02/1999 POWDER FREE NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD. KENNY H.N. LIEW
K990502 04/02/1999 PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) FLEXITECH SDN. BHD. KENNY H. N. LIEW
K990499 04/02/1999 PREPOWDERED NITRILE EXAMINATION GLOVES FLEXITECH SDN. BHD. KENNY H. N. LIEW
K981036 04/05/1999 SMARTBOND GAC INTL., INC. MARK MANNI
K982413 04/21/1999 COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS GAMBRO HEALTHCARE JEFFREY R SHIDEMAN
K982365 04/08/1999 ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT GEISTER MEDIZINTECHNIK GMBH DAGMAR S MASER
K991411 04/28/1999 GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR GEREONICS, INC. GERALD A ROST
K990567 04/05/1999 GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH GLOBAL HEALTHCARE, INC. ALAM AHMED
K991032 04/30/1999 GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 GUIDANT CORP. KOBBY DANKWAH
K991152 04/29/1999 HI-TORQUE BALANCE TREK GUIDE WIRE GUIDANT CORP. MARGARET ANDERSON
K982340 04/30/1999 EXTRACORPOREAL BLOOD CIRCUIT HAIDYLENA MEDICAL EGYPT SAMEH TAMIM
K983022 04/02/1999 SMARTCELL PROCESSING SYSTEM HARVEST TECHNOLOGIES, LLC. RICHARD LARIVIERE
K982617 04/09/1999 TRACER HEARTLAND MEDICAL SYSTEMS, INC. JOHN A HUMPHREY
K981995 04/20/1999 QUICKDRAW VENOUS CANNULA HEARTPORT, INC. MARIANNE C DRENNAN
K984194 04/30/1999 HP M2376A DEVICE LINK SYSTEM HEWLETT-PACKARD CO. MIKE HUDON
K990972 04/19/1999 HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T HEWLETT-PACKARD GMBH EGON PFEIL
K990861 04/12/1999 WOUND DRESSING/ABD PAD, MODEL #10810 HOSPITAL SPECIALTY CO. JOHN QUIGLEY
K990425 04/23/1999 SIDEKICK INFUSION KIT I-FLOW CORP. ROBERT J BARD
K991027 04/22/1999 BI-DIRECTIONAL TUNNELER IMPRA, INC. KRISTI M KISTNER
K990983 04/13/1999 MODIFICATION TO IMTEC SENDAX MDI IMTEC CORP. M.K. PATTERSON
K984222 04/15/1999 QUANTA LITE LYME IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K984234 04/15/1999 QUANTA LITE LYME IGM ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K990302 04/08/1999 IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K990449 04/13/1999 HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE INTERNATIONAL TECHNIDYNE CORP. JOHN CLAY
K984332 04/29/1999 SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, INTERNATIONAL TECHNOLOGY CONCEPTS AUSTIN BREWIN
K983610 04/30/1999 CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 INTERSURGICAL, INC. THOMAS R GUNERMAN
K981191 04/07/1999 ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 INTRATHERAPEUTICS, INC. AMY PETERSON
K990188 04/01/1999 INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 INTUITIVE SURGICAL, INC. JOHN N ZORICH, JR.
K983588 04/26/1999 SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K983579 04/23/1999 SYNTHETIC SERUM SUBSTITUTE (SSS) IRVINE SCIENTIFIC SALES CO., INC. ROBERTA L JOHNSON
K990817 04/06/1999 IPS D.SIGN PORCELAIN IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K990395 04/13/1999 BARRIER SURGICAL GOWNS JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. JANE ANN MARTIN
K990002 04/01/1999 QUICKRAY DSX 730 JULIE ALLIANCE CLAUDE D BERHOIN
K990004 04/02/1999 DCI ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K991161 04/29/1999 HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 KAY SEE DENTAL MFG. CO. CLARK SMITH
K981311 04/23/1999 COWBOY XV KCI NEW TECHNOLOGIES, INC. JUDITH HARBOUR
K990139 04/29/1999 KENSTONE KENDA USA LONNIE WELLS
K984540 04/28/1999 KERAVISION VACUUM RING SYSTEM KERAVISION, INC. HOWARD H HOLSTEIN
K990224 04/12/1999 LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET LABTICIAN OPHTHALMICS, INC. R. DAVID SCULATI
K983524 04/01/1999 LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS "PEIOLASE FOR LASERENAP") LARES RESEARCH, INC. THOMAS H LOUISELL
K983435 04/29/1999 ROTORBLADE LI MEDICAL TECHNOLOGIES, INC. RHODEMANN LI
K984527 04/29/1999 IN TOUCH DIABETES MANAGEMENT SOFTWARE LIFESCAN, INC. LORI CONZEN
K984171 04/29/1999 ENDOPEARL LINVATEC CORP. CAROL A WEIDEMAN
K990947 04/27/1999 MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY LUMENIS, INC. MICHELLE DEETON
K991138 04/23/1999 LYSTA LC CURING LIGHT, MODEL LC 2500C/BA LYSTA A/S GREGERS LYSTAGER
K983830 04/16/1999 COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER MALLINCKROOT, INC. TERESA O'SHEA
K984589 04/20/1999 PHOTOTHERAPY LAMP MEDELA, INC. STEPHEN D SMITH
K990314 04/02/1999 MULTI-CURE COMPOSITE CEMENT MEDENTAL INTL. DEBRA OLSON
K982640 04/06/1999 MEDEX 3000 SERIES SYRINGE INFUSION PUMP MEDEX, INC. CATHY CHENETSKI
K991294 04/23/1999 MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM MEDI-JECT CORP. PEGGY L HOLLAND
K990971 04/27/1999 EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 MEDICA CORP. PHOTIOS MAKRIS
K974236 04/15/1999 MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB MEDICAL COMPONENTS, INC. JEANNE M CUSH
K991097 04/23/1999 PBN DRAINAGE CATHETER GUIDEWIRES MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K984422 04/02/1999 STERILE BACK SURGICAL GOWN WITH HAND TOWEL MEDICAL STERILIZATION, INC. DAVID MORGANSTERN
K990970 04/07/1999 SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS MEDISON AMERICA, INC. BOB LEIKER
K990185 04/01/1999 MDILOG, MODEL MDC-512 MEDTRAK TECHNOLOGIES, INC. LINDA L NELSON
K990333 04/28/1999 MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 MEDTRONIC PS MEDICAL JEFFREY HENDERSON
K982145 04/14/1999 MEGA 3 MEGA MOTION, INC. PAUL GRONKA
K982144 04/14/1999 MEGA 4 MEGA MOTION, INC. PAUL GRONKA
K990189 04/19/1999 MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER MIDMARK CORP. JAMES RILE
K984151 04/28/1999 STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP MILL POND, INC. GREGORY E SANCOFF
K984355 04/01/1999 POINT SETTER MITAKA USA, INC. MAX STURGIS
K980745 04/02/1999 SECOND WIND AIR PURIFIER MONAGAN ENT., INC. GERALD C MONAGAN
K990544 04/08/1999 TRX-CG POWER TILT AND RECLINE SYSTEM MOTION CONCEPTS ALLAN BOYD
K990370 04/12/1999 MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES) MSB,UK
K991150 04/14/1999 NELLCOR PURITAN BENNETT, GOODKNIGHT 418G NELLCOR PURITAN BENNETT FRANCE DVPT. MOUSTAFA ANKI
K990622 04/29/1999 BOLD SCREW NEWDEAL S.A. NORMAN F ESTRIN
K990031 04/16/1999 NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES NIHON KOHDEN AMERICA, INC. GARY REASONER
K984504 04/15/1999 NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES NIHON KOHDEN AMERICA, INC. GARY REASONER
K990281 04/16/1999 S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS NISSEL LTD. JOHN M SZABOCSIK
K983451 04/23/1999 CHALLENGE TEST PACK NORTH AMERICAN SCIENCE ASSOC., INC. MATTHEW SLIVA
K983338 04/20/1999 FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095 NUCLETRON CORP. RALPH E SHUPING
K983343 04/02/1999 PLATO BRACHYTHERAPHY, MODEL V. 14.0 NUCLETRON CORP. RALPH E SHUPING
K983337 04/02/1999 ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068 NUCLETRON CORP. RALPH E SHUPING
K983341 04/15/1999 STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE NUCLETRON CORP. RALPH E SHUPING
K983115 04/02/1999 TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20 NUCLETRON CORP. RALPH SHUPING
K991195 04/22/1999 CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV O-TWO SYSTEMS INTL., INC. KEVIN BOWDEN
K990064 04/04/1999 DI-RHEX OPHTHALMIC DIATHERMY SYSTEM OPHTHALMIC TECHNOLOGIES, INC. GEORGE MYERS
K990417 04/14/1999 DERMACOOL OPTOMED CORP. SHAHRIAR GHAFFARI
K990984 04/08/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K984227 04/08/1999 OMEGA II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K984375 04/30/1999 OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY OSTEONICS CORP. MARYBETH NAUGHTON
K984513 04/02/1999 TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K984436 04/21/1999 PVS BASICS PARAGON VISION SCIENCES WILLIAM E MEYERS
K991095 04/28/1999 QUICKCARD HCG COMBO TEST, MODEL #9014 PHAMATECH CARL MONGIOVI
K983948 04/16/1999 BEACON, MODEL 211060 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K990256 04/01/1999 CRX WORLD SHUNT PHOENIX BIOMEDICAL CORP. COURTNEY SMITH
K990547 04/27/1999 PILLING WECK SURGICAL Y STENT FORCEPS PILLING WECK, INC. JULIE A BEAUMONT
K990322 04/01/1999 PERRY HUMERAL NAIL PIONEER SURGICAL TECHNOLOGY BURNS SEVERSON
K990804 04/29/1999 STAYFUSE PIONEER SURGICAL TECHNOLOGY BURNS SEVERSON
K990384 04/26/1999 EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 PIPER MEDICAL PRODUCTS SAMUEL DAVID PIPER, PE
K990371 04/21/1999 DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 POST MEDICAL, INC. DAVID R THEAD
K990737 04/06/1999 'ECURLINE UMBILICAL CORD CLAMP #3500 PRECISION DYNAMICS CORP. KALYNA SNYLYK
K991018 04/15/1999 ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR PRINCETON BIOMEDITECH CORP. JEMO KANG
K991079 04/15/1999 ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO PRINCETON BIOMEDITECH CORP. JEMO KANG
K991082 04/15/1999 ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO PRINCETON BIOMEDITECH CORP. JEMO KANG
K991084 04/15/1999 ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD PRINCETON BIOMEDITECH CORP. JEMO KANG
K991076 04/15/1999 ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP PRINCETON BIOMEDITECH CORP. JEMO KANG
K991078 04/15/1999 ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 PRINCETON BIOMEDITECH CORP. JEMO KANG
K991080 04/15/1999 ACCUSIGN MTD, BIOSIGN MTD PRINCETON BIOMEDITECH CORP. JEMO KANG
K984056 04/12/1999 LTV 1000 PULMONETIC SYSTEMS, INC. DOUGLAS F DEVRIES
K990866 04/29/1999 QUINTON MEDTRACK CR PLUS TREADMILL QUINTON, INC. MATTHEW J HEDLUND
K990632 04/29/1999 OPTICAL TRACKING SYSTEM (OTS) RADIONICS, INC. LISA MISTERKA BENATI
K980903 04/19/1999 RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT RADIONICS, INC. MICHAEL A ARNOLD, PH.D
K990870 04/27/1999 REDI-TEST THC REDWOOD BIOTECH, INC. JANIS FREESTONE
K990199 04/19/1999 SMARTRECORDER, MODEL 2500 RESPIRONICS, INC. BETSY CORTELLONI
K990147 04/16/1999 BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K990594 04/14/1999 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K990595 04/14/1999 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K990399 04/15/1999 ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K990418 04/13/1999 ONTRAK TESTCUP-ER M2K ROCHE DIAGNOSTICS CORP. JENNIFER L TRIBBETT
K990409 04/15/1999 ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) ROCHE DIAGNOSTICS CORP. JENNIFER L TRIBBETT
K983892 04/13/1999 COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH LUANN OCHS
K990863 04/06/1999 MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE ROSS PRODUCT DIV. ABBOTT LABORATORIES DANIEL HAMILTON
K990363 04/09/1999 BIOMESH BIODEGRADABLE GTR BARRIER SAMYANG CORP. DAVID W SCHLERF
K990511 04/27/1999 X-TIP INTRAOSSEOUS PERFORATOR SCHIFF & CO. ROBERT SCHIFF
K984031 04/30/1999 SPIROVIT, MODEL SP-250 SCHILLER AG MARKUS BUETLER
K990939 04/20/1999 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. CAROL ADILETTO
K990206 04/21/1999 SERIM BLOOD LEAK TEST STRIP SERIM RESEARCH CORP. ROBERT J CARRICO
K990790 04/02/1999 VISION PORCELAIN SERVO DENTAL USA, INC. ANGELIKA RINEHART
K990175 04/21/1999 SHEATHES (NON-LATEX), STERILE SHEATHING TECHNOLOGIES, INC. LAWRENCE S POLAYES
K990715 04/16/1999 SHIMADZU CEILING TUBE SUPPORT CH-30GH SHIMADZU CORP. MICHAEL FISHBACK
K984156 04/21/1999 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION SHIMADZU MEDICAL SYSTEMS MICHAEL FISHBACK
K990491 04/05/1999 ANGIO-CT MIYABI SIEMENS MEDICAL SOLUTIONS USA, INC. ALICIA BUSTOS-JUERGENSEN
K983732 04/21/1999 THORAX FD AND MULTIX FD SIEMENS MEDICAL SOLUTIONS USA, INC. MALGORZATA STANEK
K991067 04/27/1999 MODIFICATION OF: DAVIDSTRIP HCG SIMEX MEDICAL, INC. MICHELLE J HALL
K990528 04/30/1999 ORTHOPHOS 3/3 CEPH/3 DS SIRONA DENTAL SYSTEMS GMBH SHEILA HEMEON-HEYER
K990414 04/14/1999 SMITH & NEPHEW HANDPORT SYSTEM SMITH & NEPHEW, INC. AMY L WALTERS
K990948 04/21/1999 S575 INTRAORAL DOCKING DENTAL CAMERA SOPRO PIERRE MONTILLOT
K990527 04/23/1999 KLEENHANDS POWDERED LATEX EXAMINATION GLOVES SSN GLOVES (M) SDN BHD ANG TECK LEONG
K990526 04/23/1999 KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM SSN GLOVES (M) SDN BHD ANG TECK LEONG
K982940 04/08/1999 LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K990916 04/21/1999 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY STELLAR BIO SYSTEMS, INC. JOHN BREWER
K990915 04/21/1999 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY STELLAR BIO SYSTEMS, INC. JOHN BREWER
K990458 04/16/1999 STRAUMANN EXTRAORAL IMPLANT SYSTEM STRAUMANN USA LINDA JALBERT
K990214 04/22/1999 FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, INC. ROGER N WHITE
K990898 04/06/1999 PRODIGY 4 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K990129 04/12/1999 TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR THERAPY LINK, INC. CRAIG SEYL
K982505 04/02/1999 ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE TILLOTSON HEALTHCARE CORP. EDWARD MARKOVIC
K990468 04/27/1999 LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING TOP GLOVE SDN. BHD. LIM WEE CHAI
K984389 04/09/1999 TOP WHOLESOME FACE MASK TOP WHOLESOME ENTERPRISE CO., LTD. URAI CHAROENSUK
K990260 04/15/1999 OPART TOSHIBA AMERICA MRI, INC. HSU CHANG
K990007 04/01/1999 OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. KEN NEHMER
K983461 04/13/1999 UNI-FLEX RESIN TRANS-ATLANTIC DENTAL CAROLINE M ZALESKI
K990523 04/30/1999 B2C, ESPACE REVISION CUP SYSTEM TURNKEY INTERGRATION USA, INC. DOUGLAS W STUART
K990307 04/01/1999 OMNI-FIX, NAIL SYSTEM TURNKEY INTERGRATION USA, INC. DOUGLAS W STEWART
K990387 04/20/1999 ENDOMETRIAL SAMPLER U.A. MEDICAL PRODUCTS, INC. FANISH ENGINEER
K990262 04/07/1999 CLEARPLAN EASY HOME PREGNANCY TEST UNIPATH LTD. LOUISE ROBERTS
K990406 04/16/1999 KINGLI ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. DANIEL YE HUA
K990951 04/01/1999 MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR M CLAVELLI
K990952 04/01/1999 NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR M CLAVELLI
K984446 04/16/1999 `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH UROCOR, INC. STANLEY L MILLS
K990123 04/12/1999 PVR-100/VASOGRAM VASOCOR, INC. JEFF RAINES
K981668 04/07/1999 SMARTVENT 201 PORTABLE VENTILATOR VERSAMED LTD. SHOSHANA FRIEDMAN
K990367 04/21/1999 PDQ AND PDQ-TI ABUTMENT VIDENT BARBARA J LEWANDOWSKI
K991151 04/26/1999 VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW VILEX, INC. ABRAHIM LAVI
K991197 04/26/1999 VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 VILEX, INC. ABRAHIM LAVI
K990919 04/15/1999 STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG VISUALIZATION TECHNOLOGY, INC. PETER OHANIAN
K984526 04/08/1999 ACUSEAL CARDIOVASCULAR PATCH W.L. GORE & ASSOCIATES,INC TIMOTHY J RYNN
K991029 04/23/1999 RAPIDFLAP CRANIAL CLAMP WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K983512 04/28/1999 WATER TREATMENT SYSTEM FOR HEMODIALYSIS WATER VAULT, INC. MICHAEL J PETERSON
K990231 04/13/1999 WILTEK HOT BIOPSY FORCEPS WILTEK MEDICAL, INC. JON S WILSON
K991044 04/23/1999 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) WRP SPECIALTY PRODUCTS SDN. BHD. CHENG HEAN KHOO
K990749 04/02/1999 SOF-SUCTION FLUID EVACUATION SYSTEM X-TECH MEDICAL, LLC. EDGAR A RAININ
K990452 04/29/1999 ORLIGHT 2000 SURGICAL LASER SYSTEM YBEAM TECHNOLOGIES, INC. JUDY F GORDON
K990170 04/13/1999 HOLTER 2000 ZYMED MEDICAL INSTRUMENTATION GRETEL LUMLEY


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