FDA 510(k) Applications Received During December, 1998

FDA 510(k) Number Submission Date Device Name Applicant Contact
K984637 12/31/1998 THE 3PM EGG MACHINE 3PM CO., INC. DANIEL J MANELLI
K984352 12/04/1998 AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR AARON MEDICAL INDUSTRIES J. ROBERT SARON
K984491 12/17/1998 SYSTEM U3 FOR CEFUROXIME AB BIODISK ANNE BOLMSTROM
K984581 12/23/1998 SYSTEM U3 FOR CEPHALOTHIN AB BIODISK ANNE BOLMSTROM
K984569 12/23/1998 AB2 MED-FLO SOLUTION SET AB2 MEDICAL PRODUCTS, LLP ARTHUR CHANDLER,III
K984301 12/02/1998 ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES LAURA L GRANITZ
K984489 12/17/1998 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES ACCUMED INTL., INC. CYNTHIA C KNAPP
K984563 12/23/1998 THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. LUANNE TERMEER
K984367 12/07/1998 ACTIVX ADORNO ROGERS TECHNOLOGY PAUL GIBB
K984584 12/24/1998 AIR TECHNIQUES' DENTO-VAC AIR TECHNIQUES, INC. JOSEPH CAREY
K984616 12/29/1998 BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K984613 12/29/1998 BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION ALBERT BROWNE LTD. CYNTHIA NOLTE
K984575 12/23/1998 MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 ALCON LABORATORIES RALPH H LARSEN
K984573 12/23/1998 OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP ALCON LABORATORIES RALPH H LARSEN
K984383 12/08/1998 ULTRACARE NEUTRALIZING TABLETS ALLERGAN, INC. PAUL J NOWACKI
K984525 12/21/1998 "RAPID DRUG SCREEN" 5-PANEL WITH METHAMPHETAMINE TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K984486 12/17/1998 PULSEMASTER DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. JOHN G SULEWSKI
K984558 12/23/1998 DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) ANSELL PERRY JAMES R CHATTERTON
K984559 12/23/1998 ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) ANSELL PERRY JAMES R CHATTERTON
K984392 12/08/1998 ANSELL CONDOMS ANSELL, INC. LON MCLLVAIN
K984482 12/16/1998 AVE GL-1 GUIDING CATHETER ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. NORMA J LEMAY
K984627 12/30/1998 AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER ARTERIAL VASCULAR ENGINEERING, INC. DEBORAH L HERRINGTON
K984496 12/17/1998 ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DEPAOLO
K984299 12/01/1998 AVL OPTI CRITICAL CARE ANALYZER AVL SCIENTIFIC CORP. RANDY BYRD
K984590 12/28/1998 0.9% SODIUM CHLORIDE FLUSH SYRINGE BAXTER HEALTHCARE CORP. MARCIA MARCONI
K984381 12/08/1998 BURETROL SOLUTION SETS BAXTER HEALTHCARE CORP. JUDY KANNENBERG
K984618 12/29/1998 BCI MINI-TORR PLUS, MODEL 6004 BCI INTL., INC. DONALD ALEXANDER
K984402 12/09/1998 SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT BECKMAN COULTER, INC. LUCINDA STOCKERT
K984631 12/30/1998 BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY BECTON DICKINSON MICROBIOLOGY SYSTEMS COLLEEN ROHRBECK
K984597 12/28/1998 MODIFICATION OF CUTINOVA CAVITY DRESSING BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K984599 12/28/1998 MODIFICATION OF CUTINOVA FOAM DRESSING BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K984595 12/28/1998 MODIFICATION OF CUTINOVA HYDRO DRESSING BEIERSDORF-JOBT, INC. ANGELO R PERIERA
K984593 12/28/1998 MODIFICATION OF CUTINOVA THIN DRESSING BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K984582 12/23/1998 ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX BIO-DETEK, INC. MICHAEL R DUPELLE
K984626 12/28/1998 ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 BIO-RAD ELIZABETH PLATT
K984604 12/28/1998 ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 BIO-RAD ELIZABETH PLATT
K984325 12/03/1998 ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 BIO-RAD ELIZABETH PLATT
K984625 12/28/1998 ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 BIO-RAD ELIZABETH PLATT
K984319 12/03/1998 ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 BIO-RAD ELIZABETH PLATT
K984318 12/03/1998 ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 BIO-RAD ELIZABETH PLATT
K984323 12/03/1998 ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 BIO-RAD ELIZABETH PLATT
K984324 12/03/1998 ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 BIO-RAD ELIZABETH PLATT
K984327 12/03/1998 ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 BIO-RAD ELIZABETH PLATT
K984397 12/09/1998 LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 BIO-RAD ELIZABETH PLATT
K984473 12/16/1998 LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 BIO-RAD ELIZABETH PLATT
K984398 12/09/1998 LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 BIO-RAD ELIZABETH PLATT
K984399 12/09/1998 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 BIO-RAD ELIZABETH PLATT
K984400 12/09/1998 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 BIO-RAD ELIZABETH PLATT
K984396 12/09/1998 LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 BIO-RAD ELIZABETH PLATT
K984464 12/16/1998 LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 BIO-RAD ELIZABETH PLATT
K984476 12/16/1998 LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 BIO-RAD ELIZABETH PLATT
K984475 12/16/1998 LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 BIO-RAD ELIZABETH PLATT
K984479 12/16/1998 LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 BIO-RAD ELIZABETH PLATT
K984470 12/16/1998 LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 BIO-RAD ELIZABETH PLATT
K984478 12/16/1998 LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 BIO-RAD ELIZABETH PLATT
K984462 12/16/1998 LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 BIO-RAD ELIZABETH PLATT
K984594 12/28/1998 LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 BIO-RAD ELIZABETH PLATT
K984477 12/16/1998 LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 BIO-RAD ELIZABETH PLATT
K984583 12/24/1998 THE BIOPLATE SHUNT CONNECTOR BIOMEDICS ERIC V HOHENSTEIN
K984408 12/09/1998 130 MODIFIED INTEGRAL FEMORAL COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K984390 12/08/1998 LACTOSORB PANELS AND FASTENERS BIOMET, INC. TRACY J BICKEL
K984296 12/01/1998 LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT BIOMET, INC. DARLENE HUFZIGER BINKLEY
K984623 12/30/1998 MAXIM REMOVABLE MOLDED POLY TIBIA BIOMET, INC. FRED MCCLURE
K984580 12/23/1998 BIOSACA SYSTEM BIOSYS AB (PUBL) JANE B CAMPBELL
K984372 12/07/1998 ELECSYS CALCHECK TROPONIN T BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K984419 12/10/1998 ELECSYS IGE CALCHECK BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K984326 12/03/1998 ELECYS IGE ASSAY BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K984425 12/11/1998 MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR BOEHRINGER MANNHEIM CORP. PRISCILLA A HAMILL
K984431 12/11/1998 ULTIMA AIRFLOW PRESSURE SENSOR BRAEBON MEDICAL CORP. RICHARD A BONATO
K984601 12/28/1998 CANDELA GENTLELASE II DERMATOLOGICAL LASER CANDELA CORP. JAY CAPLAN
K984485 12/17/1998 MICROSTAT 2 CHEMLINK LABORATORIES LLC. KARI E MAVIAN
K984456 12/15/1998 COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K984354 12/04/1998 MECHANICAL WHEELCHAIR COLOURS 'N MOTION JOHN G BOX
K984285 12/01/1998 OSTEOGRAM BONE DENSITOMETER COMPUMED, INC. T WHIT ATHEY
K984388 12/08/1998 HA ABSORBENT WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIIENNE MCNALLY
K984500 12/17/1998 CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM CORDIS CORP. ARIEL MACTAVISH
K984512 12/18/1998 NITRILON CORRECT-TOUCH CT INTL. MIKE KYLE
K984517 12/21/1998 CYNOSURE ERASURE LASER CYNOSURE, INC. GEORGE CHO
K984501 12/18/1998 DADE BEHRING BFTII DADE BEHRING, INC. CAROLYN K GEORGE
K984522 12/21/1998 MODIFICATION OF TSRH SPINAL SYSTEM DANEK MEDICAL, INC. RICHARD W TREHARNE
K984339 12/04/1998 MEDART 455 SCANNER SYSTEM DEL MAR TECHNOLOGIES, INC. JAN K ENEMAERK
K984387 12/08/1998 R-30 AESTHETIC RESTORATIVE DENTSPLY INTL. P JEFFERY LEHN
K984458 12/15/1998 DEPUY ACE SPIDER PLATE DEPUY ACE MEDICAL CO. KATHLEEN DRAGOVICH
K984348 12/04/1998 TIMX LOW BACK SYSTEM DEPUY MOTECH ACROMED PAM CORSILLO
K984350 12/04/1998 VSP SYSTEM DEPUY MOTECH ACROMED PAM CORSILLO
K984459 12/15/1998 DEPUY PROFILE FEMORAL HIP WITH POROCOAT DEPUY ORTHOPAEDICS, INC. SALLY FOUST
K984541 12/21/1998 GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K984378 12/07/1998 DEPUY ACROMED MOSS SPINAL SYSTEM DEPUY, INC. LYNNETTE WHITAKER
K984322 12/03/1998 DIDECO D920, LILLIPUT 1 TWIN RESERVOIR DIDECO S.P.A. BARRY SALL
K984466 12/16/1998 DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 DILON TECHNOLOGIES, INC. LEE H FAIRCHILD
K984349 12/04/1998 DORNIER MEDILAS R DORNIER CAROL WERNECKE
K984591 12/28/1998 DORNIER MEDILAS H/2 DORNIER SURGICAL PRODUCTS, INC. CAROL WERNECKE
K984611 12/29/1998 DRAGER SOLA SERIES, MODELS 1000/700/500/300 DRAGER MEDIZINTECHNIK GMBH FRANK CLANZETT
K984577 12/23/1998 DRAGER OXYLOG 2000 DRAGER, INC. HARALD KNEUER
K984564 12/23/1998 ETHYL CHLORIDE DISPENSER DUKAL CORP. ED RASOM
K984337 12/03/1998 ELASTYLON POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. STEPHEN L THOMPSON
K984328 12/03/1998 LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 ELEKTA INSTRUMENT AB CAROL PATTERSON
K984544 12/22/1998 THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S ENTERIC PRODUCTS, INC. JEFFREY PEACOCK
K984345 12/04/1998 AROMAPATCH ENVIS, INC. STEVE WOODY
K984465 12/16/1998 OXYCONALPHA WITH OPTION ECG ERICH JAEGER B.V. LEON DEN BAKKER
K984640 12/31/1998 THERMAL ANGEL ESTILL MEDICAL TECHNOLOGIES, INC. THOMAS KISTNER
K984297 12/01/1998 MAGNA ABUTMENT FACTOR, II, INC. JOHN D MCFALL
K984539 12/21/1998 FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING FERRIS MFG. CORP. THEODORE THORSEN
K984586 12/24/1998 FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS FRESENIUS HEMOTECHNOLOGY, INC. VIRGINIA R SINGER
K984365 12/07/1998 GC UNIFAST TRAD GC AMERICA, INC. TERRY L JORITZ
K984505 12/18/1998 MIRACLE MIX POWDER/LIQUID GC AMERICA, INC. TERRY L JORITZ
K984394 12/08/1998 ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP. MARGARET ANDERSON
K984442 12/14/1998 AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 HAND BIOMECHANICS LAB, INC. TIMOTHY STALLINGS
K984546 12/22/1998 BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK HEMOCLEANSE, INC. STEPHEN R ASH
K984286 12/01/1998 HEARTSTREAM ELECTRODE ADAPTER HEWLETT-PACKARD CO. WILLIAM D JORDAN
K984432 12/14/1998 DALL-MILES CABLE GRIP (A-GRIP) HOWMEDICA OSTEONICS CORP. FRANK MAAS
K984305 12/02/1998 ZETA MULTIZONE LOCKING NAIL SYSTEM HOWMEDICA, INC. JOSEPH VOLPE
K984307 12/02/1998 MODIFICATION OF: RHEO DOPPLEX II HUNTLEIGH HEALTHCARE, INC. AUDREY WITKO
K984313 12/02/1998 HTU3 HYOX SYSTEMS LTD. HOWARD M HOLSTEIN
K984441 12/14/1998 KVO CHECK VALVE ACCESSORY, MODEL EV-0001 I-FLOW CORP. SHANE P NOEHRE
K984502 12/18/1998 NERVE BLOCK INFUSION KIT I-FLOW CORP. ROBERT J BARD
K984638 12/31/1998 PARAGON BOLUS ACCESSORY SET I-FLOW CORP. ROBERT J BARD
K984523 12/21/1998 IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS IGEL VISION CARE PTE LTD. JOHN M SZABOCSIK
K984357 12/07/1998 TRANSFX EXTERNAL FIXATION SYSTEM IMMEDICA, INC. ROY BOGERT
K984291 12/01/1998 CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT IMPLEX CORP. JOHN SCHALAGO
K984290 12/01/1998 IMPLEX RADIAL HEAD REPLACEMENT SYSTEM IMPLEX CORP. JOHN SCHALAGO
K984570 12/23/1998 MINOLTA PULSOX-3/MINOLTA PULSOX-3I IN-X CORP. CHARLIE HENRY
K984600 12/28/1998 METRA PS PROCEDURE KIT INLET MEDICAL, INC. MARK STERRETT
K984490 12/17/1998 SUTURELESS ANCHOR INNOVASIVE DEVICES, INC. KATHLEEN MORAHAN
K984336 12/03/1998 QUANTA LITE GBM ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K984537 12/21/1998 KERATOME SYSTEM, MODEL K3000 INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. CHARLES VASSALLO
K984437 12/14/1998 QUANTEX ASO-CRP-RP CONTROL II INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K984332 12/03/1998 SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, INTERNATIONAL TECHNOLOGY CONCEPTS AUSTIN BREWIN
K984578 12/23/1998 SYNERGY D2 SPINAL IMPLANTS INTERPORE CROSS INTL. LYNN M RODARTI
K984481 12/16/1998 EXHALATION VALVE INTERSURGICAL, INC. THOMAS R GUNERMAN
K984294 12/01/1998 MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES INTERVASCULAR, INC. JAMES S MILLER
K984405 12/09/1998 ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 INTRACOM CORP. JAMES A NATIONS
K984295 12/01/1998 INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) INVACARE CORP. EDWARD A KROLL
K984447 12/14/1998 MODEL ACTION AT II MANUAL WHEELCHAIR INVACARE CORP. EDWARD A KROLL
K984451 12/15/1998 D-SIGN I (R&D PROJECT DW263 #24) IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K984587 12/24/1998 ALLROUND-E (CODE NAME RD 1710) J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K984338 12/03/1998 JOSTRA HL-20 TWIN PUMP JOSTRA BENTLEY KATHY JOHNSON
K984551 12/22/1998 INFRARED EAR THERMOMETER, MODEL KI-8120 K-JUMP HEALTH CO., LTD. ROBERT J ZAPPA
K984553 12/22/1998 TALKING DIGITAL THERMOMETER, MODEL KV-171 K-JUMP HEALTH CO., LTD. ROBERT J ZAPPA
K984369 12/07/1998 DCI ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K984540 12/21/1998 KERAVISION VACUUM RING SYSTEM KERAVISION, INC. HOWARD H HOLSTEIN
K984380 12/08/1998 DISPO ETCH KIS PRODUCTS REUBEN HERTZ
K984424 12/11/1998 AURA DYE LASER SYSTEM (ADLS) LASERSCOPE PAUL H HARDIMAN
K984391 12/08/1998 "THE LIBERATOR" LIBERATOR WHEELCHAIRS, INC. BONNIE BROMLEY
K984527 12/21/1998 IN TOUCH DIABETES MANAGEMENT SOFTWARE LIFESCAN, INC. LORI CONZEN
K984609 12/28/1998 ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III LITE SPECIALTY METAL WORKS, INC. DAVID R COLE
K984493 12/17/1998 MAXXIM; MAXXIM HD MAJOR MOBILITY PRODUCTS, INC. SCOTT SCHWEISS
K984589 12/24/1998 PHOTOTHERAPY LAMP MEDELA, INC. STEPHEN D SMITH
K984422 12/10/1998 STERILE BACK SURGICAL GOWN WITH HAND TOWEL MEDICAL STERILIZATION, INC. DAVID MORGANSTERN
K984639 12/31/1998 THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER MEDISON AMERICA, INC. BOB LEIKER
K984434 12/14/1998 MEDIVISION LAPAROSCOPE MEDIVISION SCOPE SERVICE CENTER, INC. WAYNE B STERNER
K984418 12/10/1998 UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET MEDRAD, INC. FRANK W PELC III
K984435 12/11/1998 MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M MEDTRONIC VASCULAR JULIE SHERMAN
K984343 12/04/1998 PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST MERIDIAN DIAGNOSTICS, INC. ALAN NICHOL
K984346 12/04/1998 PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST MERIDIAN DIAGNOSTICS, INC. ALAN NICHOL
K984530 12/21/1998 DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE METRIKA, INC. ERIKA B AMMIRATI
K984467 12/16/1998 FUSICRYL MICRO DENTAL LABORATORIES NICOLAS E AZAR
K984355 12/07/1998 POINT SETTER MITAKA USA, INC. MAX STURGIS
K984370 12/07/1998 HYPERGEL 20% HYPERTONIC SALINE GEL MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K984371 12/07/1998 MEPITEL NON ADHERENT SILICONE DRESSING MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K984368 12/07/1998 NORMLGEL 0.9% ISOTONIC SALINE GEL MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K984628 12/30/1998 MODIFICATION OF MOSS P.E.G. TRAY MOSS TUBES, INC. HARRY SCHLAKMAN
K984310 12/02/1998 MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE MOSS TUBES, INC. HARRY A SCHLAKMAN
K984629 12/30/1998 MOSS TUBES, INC. NASAL TUBE - MARK IV MOSS TUBES, INC. HARRY SCHLAKMAN
K984561 12/23/1998 SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B MSR, INC. MARY MCNAMARA
K984427 12/11/1998 EXCELSIOR PORCELAIN SYSTEM NEY DENTAL, INC. ANDREW J PIETROBONO
K984520 12/21/1998 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 NICHOLS INSTITUTE DIAGNOSTICS JIM WONG
K984504 12/18/1998 NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES NIHON KOHDEN AMERICA, INC. GARY REASONER
K984409 12/09/1998 ELK LASER FILM DIGITIZER NISHIMOTO SANGYO CO., LTD. GARY J ALLSEBROOK
K984287 12/01/1998 PROVISIONAL DENTAL IMPLANT SYSTEM NOBEL BIOCARE UAS INC JEFF HAUSHEER
K984417 12/10/1998 BIPOLAR GRASPING FORCEPS BIQ+ OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K984358 12/07/1998 OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K984579 12/23/1998 CAPNO PROBE A OPTICAL SENSORS, INC. GARY J SYRING
K984497 12/17/1998 TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 ORIENTAL SYSTEM TECHNOLOGY, INC. SUSAN D GOLDSTEIN-FALK
K984303 12/02/1998 VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE SHULMAN
K984288 12/01/1998 VITROS CHEMISTRY PRODUCTS PHBR SLIDES ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A SHULMAN
K984289 12/01/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K984321 12/03/1998 VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS, INC. ANNE ZAVERTNIK
K984331 12/03/1998 ODI ULTIMATE COMPRESSION HIP SCREW ORTHOPEDIC DESIGNS, INC. JEFF GODSTED
K984529 12/21/1998 HEMOCHEK SAMPLE COLLECTION KIT OSBORN LABORATORIES, INC. GILBERT P BOURKE III
K984361 12/07/1998 ORAL-EZE ORAL FLUID COLLECTION SYSTEM OSBORN LABORATORIES, INC. GILBERT P BOURK III
K984353 12/07/1998 OSTEO 9MM IC TIBIAL NAIL OSTEONICS CORP. KATE SUTTON
K984585 12/24/1998 OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE OSTEONICS CORP. MARYBETH NAUGHTON
K984375 12/07/1998 OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY OSTEONICS CORP. MARYBETH NAUGHTON
K984302 12/02/1998 OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS OSTEONICS CORP. KATE SUTTON
K984608 12/28/1998 GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K984513 12/18/1998 TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K984436 12/14/1998 PVS BASICS PARAGON VISION SCIENCES WILLIAM E MEYERS
K984528 12/21/1998 PARKER FLEX-TIP TRACHEAL TUBE PARKER MEDICAL ASSOC. JEFFREY D PARKER
K984356 12/07/1998 NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP) PERUSAHAAN GETAH ASAS SDN BHD BOB CHAN
K984605 12/28/1998 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K984545 12/22/1998 RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. P. ALTMAN
K984401 12/09/1998 NEUROMAG VECTORVIEW PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K984588 12/24/1998 PHASED ARRAY FLEXIBLE CARDIAC COIL PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K984492 12/17/1998 TIGRAN HIP PROSTHESIS PONMED LTD. JEFFREY R SCHIDEMAN
K984449 12/14/1998 NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM PT. IRAMA DINAMIKA LATEX ANIL TANEJA
K984379 12/07/1998 NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM PURITAN BENNETT CORP. ROBBIE WALSH
K984535 12/21/1998 PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION PURITAN BENNETT CORP. ANN-MARIE BUTLER
K984463 12/16/1998 QUANTASE PHE/GAL SCREENING ASSAY QUANTASE LTD. R. STEWART CAMPBELL
K984433 12/14/1998 QUANTECH CK-MB ASSAY QUANTECH LTD. ROBIN J HELLEN
K984552 12/22/1998 COOL-TIP RF SYSTEM RADIONICS, INC. JEFFREY R MANNION
K984494 12/17/1998 RANDOX ALBUMIN RANDOX LABORATORIES, LTD. P ARMSTRONG
K984428 12/04/1998 SULLIVAN AUTOSET NASAL CPAP SYSTEM RESMED LTD. SCOTT DUDEVOIR
K984547 12/22/1998 DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS RESOUND CORP. GARY ROESEL
K984407 12/09/1998 BIPAP HARMONY S/T, MODEL 1001445 RESPIRONICS, INC. DAVID J VANELLA
K984607 12/28/1998 PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K984304 12/02/1998 RIWO DRIVE GENERATOR RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K984521 12/21/1998 RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K984614 12/29/1998 NORMAL SALINE FLUSH SYRINGE ROCAP DIV. OF SABRATEK CORP. AVIA TONEY
K984483 12/16/1998 A-SOFT RELINER S & C POLYMER GMBH JURGEN ENGELBRECHT
K984484 12/16/1998 LC MICROHYBRID S & C POLYMER GMBH JURGEN ENGELBRECHT
K984415 12/10/1998 S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F S.S. WHITE TECHNOLOGIES, INC. DAVE TAYLOR
K984374 12/07/1998 SURGISORB SAMYANG CORP. DAVID W SCHLERF
K984444 12/14/1998 INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 SANDHILL SCIENTIFIC, INC. LINDA L DIEDERICH
K984641 12/31/1998 FLEXISCOPE OPTOMODUL SCHOELLY FIBEROPTIC, GMBH JOSEPH RESS
K984556 12/23/1998 SCICAN CLASSIC SCHOLLY FIBEROPTIC GMBH CARSTEN SCHLENKER
K984460 12/16/1998 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI HUAMAO GLOVES CO., LTD. SUSAN D GOLDSTEIN-FALK
K984461 12/16/1998 PRE-POWDER VINYL PATIENT EXAMINATION GLOVES SHANGHAI HUAMAO GLOVES CO., LTD. SUSAN D GOLDSTEIN-FALK
K984610 12/29/1998 POWDER FREE NITRILE EXAMINATION GLOVES SHIVA MEDICARE LTD. JAMES F LOGAN
K984615 12/29/1998 POWDERED NITRILE EXAMINATION GLOVES SHIVA MEDICARE LTD. JAMES F LOGAN
K984634 12/30/1998 3D-ANGIO SIEMENS MEDICAL CORP. MALGORZATA STANEK
K984574 12/23/1998 INFINITY GLUCOSE REAGENT SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT
K984506 12/18/1998 SD-100 SKYEAR THERMOMETER SKYLARK DEVICE CO., LTD. GEORGE K C CHEN
K984320 12/03/1998 BIOABSORBABLE INTERFERENCE SCREWS SMITH & NEPHEW, INC. DEMETRIOS TSAKONAS
K984550 12/22/1998 PRE-THREADED ENDOBUTTON SMITH & NEPHEW, INC. SUSAN A FINNERAN
K984360 12/07/1998 COLORADO II SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K984518 12/21/1998 SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL SONIC INNOVATIONS, INC. JEANNETTE S JOHNSON
K984562 12/23/1998 VIVOSONIC SONOTECH, INC. MARGARET J LARSON
K984395 12/08/1998 SURGEON'S GLOVES SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. N. PARAMASIVAN
K984340 12/04/1998 STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 STERNGOLD/IMPLAMED GORDON NELSON
K984341 12/04/1998 STERNVANTAGE VARNISH LC, MODEL 221001 STERNGOLD/IMPLAMED GORDON NELSON
K984457 12/15/1998 WORLD CLASS WHEELED CHAIR, MODEL SS SUITER MEDICAL L.L.C. JAMES P SUITER
K984536 12/21/1998 REMOVABLE CUFF ABUTMENT SULZER CALCITEK, INC. FOSTER BOOP
K984309 12/02/1998 NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. HIDEAKI OCHIAL
K984311 12/02/1998 NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE SUMIRUBBER INDUSTRIES (KEDAH) SDN. BHD. HIDEAKI OCHIAI
K984362 12/07/1998 ENLIGHT LV SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K984543 12/21/1998 SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 SYNTEC SCIENTIFIC CORP. TED Y SHI
K984364 12/07/1998 SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 SYNTEC SCIENTIFIC CORP. TED Y SHI
K984602 12/28/1998 SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM SYNTEC SCIENTIFIC CORP. TED Y SHI
K984498 12/17/1998 SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM SYNTHES (USA) ANGELA J SILVESTRI
K984377 12/03/1998 SYNTHES SPINE CERVIFIX SYSTEM SYNTHES (USA) JONATHAN M GILBERT
K984612 12/24/1998 SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM SYNTHES SPINE JONATHAN GILBERT
K984376 12/07/1998 ENDOR 2000 T.C. MEDICAL, INC. LINCOLN ONG
K984382 12/08/1998 ACCU GUIDE TAYMAN MEDICAL, INC. VAUGHN WEEKS
K984443 12/14/1998 ORBSCAN TECHNOLAS PERFECT VISION GMBH BETSY M JOHNSON
K984576 12/23/1998 K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K TERUMO EUROPE N.V. M J AERTS
K984619 12/29/1998 BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K984384 12/08/1998 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 THERMO BIOANALYSIS CORP. JANET A MCGRATH
K984565 12/23/1998 TMC-EASY-302 TMC MAGNETICS & MACHINERY CORP. SUSAN D GOLDSTEIN-FALK
K984389 12/08/1998 TOP WHOLESOME FACE MASK TOP WHOLESOME ENTERPRISE CO., LTD. URAI CHAROENSUK
K984359 12/07/1998 AIA-PACK TROPONIN I ASSAY TOSOH MEDICS, INC. LORI ROBINSON
K984414 12/10/1998 XRE COLLIMATOR WITH SPECTRAL FILTER TREX MEDICAL CORP. WAYNE V LOOMER
K984488 12/17/1998 SHEER THIN TWE COMPANIES, INC. KEITH F HEINTZ
K984342 12/04/1998 ANTERIOR CERVICAL PLATING SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC KAREN F JURCZAK
K984438 12/14/1998 MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHRISTOPHER A GRAHAM
K984446 12/14/1998 `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH UROCOR, INC. STANLEY L MILLS
K984532 12/21/1998 CADPLAN HELIOS OPTION 6.0 VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K984567 12/23/1998 VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) VENTANA, INC. JUDITH FREDERICK
K984524 12/21/1998 AZTECH 70 VILLA SISTEMI MEDICALI S.P.A. AL SOSA
K984468 12/16/1998 VITAL PEP VITAL SIGNS, INC. ANTHONY P MARTINO
K984508 12/18/1998 SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD W & H DENTALWERK BUERMOOS GMBH HERBERT TRASCHWANDTNER
K984526 12/21/1998 ACUSEAL CARDIOVASCULAR PATCH W.L. GORE & ASSOCIATES,INC TIMOTHY J RYNN
K984534 12/21/1998 PRECLUDE ACUSEAL DURA SUBSTITUTE W.L. GORE & ASSOCIATES,INC JOHN NICHOLSON
K984503 12/18/1998 ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 WALLACE A. ERICKSON & CO. ABNER T DE LA CRUZ
K984306 12/02/1998 `THE INSEMINATOR' (PROPOSED) WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K984448 12/14/1998 BIRCOLL BALLOON DISSECTOR WELLS JOHNSON CO. KEN RODENBURG
K984406 12/09/1998 XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM XITEC, INC. SHEILA M HEMEON-HEYER
K984363 12/07/1998 XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM XOMED, INC. DAVID TIMLIN
K984298 12/02/1998 Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI Z-KAT, INC. RONY ABOVITZ
K984347 12/04/1998 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K984516 12/18/1998 THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K984315 12/03/1998 THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K984317 12/03/1998 THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K984596 12/28/1998 VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES ZYMETX, INC. CRAIG D SHIMASAKI


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