FDA 510(k) Applications Received During November, 1997

FDA 510(k) Number Submission Date Device Name Applicant Contact
K974445 11/25/1997 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 3M HEALTH CARE LINDA JOHNSEN
K974553 11/17/1997 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) 3M HEALTH CARE LINDA JOHNSEN
K974279 11/14/1997 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) 3M HEALTH CARE LINDA JOHNSEN
K974138 11/03/1997 ROCKET ELECTRODE A & A MEDICAL, INC. JIHAD MANSOUR
K974382 11/21/1997 ACKERMANN SURGICAL INSTRUMENTS ACKERMANN INSTRUMENTE GMBH FRANK FERGUSON
K974474 11/26/1997 PEGASYS INTOUCH ADAC LABORATORIES DENNIS W HENKELMAN
K974467 11/26/1997 AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08 AESCULAP-MEDITEC NORTH AMERICA WILLIAM T KELLEY
K974204 11/10/1997 VISTACAM OMNI AND VIASTCAM OMNI (IC) AIR TECHNIQUES, INC. JOSEPH CAREY
K974248 11/12/1997 WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM AIR-SHIELDS, INC. MARCI L GOLDFINGER
K974239 11/12/1997 AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
K974332 11/18/1997 VARIABLE PRESSURE SYRINGE PUMP ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K974281 11/14/1997 ALCON CONTACT LENS CASE ALCON LABORATORIES RALPH H LARSEN
K974146 11/03/1997 PARACENTESIS CATHETER DEVICE ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K974356 11/19/1997 SURGEON'S GLOVES AMERICAN HEALTH PRODUCTS, INC. TONY K DJIE
K974142 11/03/1997 HM-RUBY AMERICAN LASERS, INC. DAVID K QUON
K974235 11/12/1997 AMPLAID AM50 AMPLIFON S.P.A. DANIEL KAMM
K974455 11/25/1997 ANATOM 1000 (A MINUS, A-) ANALOGIC CORP. ROBERT H FRENCH
K974218 11/10/1997 DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES ANSELL PERRY JAMES R CHATTERTON
K974242 11/12/1997 ARGOSY PROGRAMMABLE ONQUE ARGOSY ELECTRONICS RONALD A SCICLUNA
K974488 11/26/1997 AIRPREP SYSTEM - MODEL 9001 ASI MEDICAL, INC. JOHN W MCPEEK
K974487 11/26/1997 SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 ASI MEDICAL, INC. JOHN W MCPEEK
K974496 11/28/1997 A-2000 EEG MONITOR WITH BIS ASPECT MEDICAL SYSTEMS, INC. CHRISTINE MORGIDA
K974127 11/03/1997 HYDRA METER AUTOMATA INSTRUMENTATION, INC. LINDA V MASANO
K974145 11/03/1997 V3 VALVE B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K974347 11/19/1997 "BALDUR" NON-STERILE COTTON SPONGES BALDUR SYSTEMS CORP. DAVID HU, PH.D.
K974468 11/26/1997 PHOTONIC STIMULATOR BALES SCIENTIFIC, INC. MAURICE BALES
K974196 11/07/1997 MEGAVAC SYSTEM BARRY J. KAPLAN, INC. BARRY J KAPLAN
K974155 11/04/1997 BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT BAXTER HEALTHCARE CORP. TOM HUMPHREY
K974397 11/21/1997 STERILE SALINE FOR CATHETER CARE BAXTER HEALTHCARE CORP. MARCIA MARCONI
K974363 11/19/1997 BECTON DICKINSON BLUNT PLASTIC CANNULA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY W MORGAN
K974452 11/25/1997 VIGIL LIPID CONTROL BECKMAN INSTRUMENTS, INC. RICHARD T ROSS
K974360 11/19/1997 MULTITEST CD3/CD8/CD45/CD4 BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS CINDY MORROW
K974433 11/24/1997 CHROMOPHARE D 500, CHROMOPHARE D 530 BERCHTOLD HOLDING GMBH WOLFRAM K HILL
K974152 11/04/1997 OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) BERNAFON-MAICO, INC. RAY ENROTH
K974211 11/10/1997 OPUS 2 - FULL CONCHA SERIES - ITE BERNAFON-MAICO, INC. RAY ENROTH
K974408 11/24/1997 PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS BIOCOMPATIBLES EYEWEAR, INC. LISA HAHN
K974475 11/26/1997 THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012 BIOCONTROL TECHNOLOGY, INC. PATRICK J COOPER
K974136 11/03/1997 CRANIOFACIAL ANCHORS BIOMET, INC. MARY L VERSTYNEN
K974309 11/17/1997 LACTOSORB PANELS BIOMET, INC. MARY VERSTYNEN
K974192 11/07/1997 BIOSENSOR HOLTER MONITOR SYSTEM BIOSENSOR CORP. STEVE SPRINGROSE
K974461 11/25/1997 TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL BIOSITE INCORPORATED JOHN F BRUNI
K974392 11/21/1997 LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM BIOVISION GMBH FOSTER BOOP
K974483 11/26/1997 NTL-FLOW BISCO, INC. JAMES L SANDRIK
K974491 11/28/1997 ACCU-CHEK A1C HEMOGLOBIN TEST BOEHRINGER MANNHEIM CORP. MIKE FLIS
K974384 11/21/1997 ELECSYS CALCHECK FOLATE BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K974383 11/21/1997 ELECSYS CALCHECK VITAMIN B12 BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K974421 11/24/1997 ELECSYS CK-MB STAT BOEHRINGER MANNHEIM CORP. JODY J SAVAGE
K974189 11/07/1997 ELECSYS PSA (ON ELECSYS 1010) BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K974261 11/13/1997 ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K974247 11/12/1997 40 CC GRANDE BOSTON SCIENTIFIC CORP. LEO BASTA
K974379 11/20/1997 ULTRANEB BREMED ITALIA, S.R.L. MARK HEBENSTREIT
K974393 11/21/1997 VASO PRESS SYSTEM BRITT CORP., INC. J. JAMES BRITTON
K974160 11/05/1997 BRUXTRAK MATERIAL BRUXCARE, L.L.C. JUSTUS N BAIRD
K974295 11/14/1997 BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING BYRON MEDICAL TODD LANE
K974381 11/20/1997 CANDELA GENTLELASE GL DERMATOLOGICAL LASER CANDELA CORP. JAN CAPLAN
K974357 11/19/1997 UTERINE MANIPULATOR/INJECTOR CATHETER RESEARCH, INC. JOHN A STEEN, PH.D.
K974497 11/28/1997 INTELECT CHATTANOOGA GROUP, INC. JOE ELROD
K974325 11/18/1997 CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN CHIRON DIAGNOSTICS CORP. WILLIAM J PIGNATO
K974389 11/21/1997 KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER CLINICAL INNOVATIONS, INC. WM. DEAN WALLACE
K974198 11/10/1997 TAKY-SPIKE PLUS CLINICO REINHARD HOPF
K974371 11/20/1997 CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE CLK INTL., INC. GEORGE Q KUO
K974301 11/17/1997 CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER CLK INTL., INC. GEORGE Q KUO
K974465 11/26/1997 SYNERGY COLTENE/WHALEDENT INC. H.J. VOLGELSTEIN
K974424 11/24/1997 COMFORT RUBBER GLOVES INDUSTRIES SDN BHD COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHEE YONG FOO
K974190 11/04/1997 CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER CONSOLIDATED PRODUCTS & SERVICES, INC. WAYNE KRITZMAN
K974304 11/17/1997 GERMICIDAL CLOTH CONVATEC, A DIVISION OF E.R. SQUIBB & SONS MIKE EBERS
K974205 11/10/1997 KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIENNE MCNALLY
K974448 11/25/1997 CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM CORDIS CORP. ARIEL MACTAVISH
K974222 11/12/1997 CES MASSTRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. LISA WELLS
K974494 11/28/1997 RENAMEL FLOWABLE COMPOSITE COSMEDENT, INC. MICHAEL O'MALLEY
K974320 11/17/1997 CRYOGEN CARDIAC CRYOSURGICAL SYSTEM CRYOGEN, INC. CHERYL L SHEA
K974256 11/13/1997 ECAT PET SCANNERS CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K974343 11/19/1997 DADE INNOVIN DADE INTL., INC. RADAMES RIESGO
K974178 11/06/1997 PASSPORT 5L-CE MODEL 0998-00-0131XXX DATASCOPE CORP. RUSSELL OLSEN
K974130 11/03/1997 VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE DEJARNETTE RESEARCH SYSTEMS ERIC JOHN FINEGAN
K974140 11/03/1997 ADHESIVE HYBRID IONOMER CEMENT DENTSPLY INTL. JEFFERY P LEHN
K974245 11/12/1997 DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI DEPUY ACE MEDICAL CO. KATHLEEN DRAGOVICH
K974223 11/12/1997 NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES DERLIN COMPANY LTD. JOHN BUCHER
K974396 11/21/1997 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE DIAMETRICS MEDICAL, INC. STEVE BOEH
K974193 11/07/1997 NARKOMED ULTRASONIC FLOW SENSOR DRAEGER MEDICAL, INC. JAMES J BRENNAN
K974176 11/06/1997 BABYLOG 8000 PLUS DRAGER, INC. HARALD KNEUEAR
K974132 11/03/1997 VOICE MASTER PROSTHESIS E. BENSON HOOD LAB, INC. ANTHONY M SACCHETTI
K974259 11/13/1997 VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES RESEARCH MEDICAL R D HIBBERT
K974255 11/13/1997 CD-R STATION AND VRS-2000 ELECTROMED INTL., LTD. JAMES RIEDL
K974344 11/19/1997 CT SCOPE ELSCINT, INC. STEVEN KAY
K974294 11/14/1997 ENCORE LINEAR POROUS COATED HIP ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K974470 11/26/1997 VTU-E VACUUM ERECTION SYSTEM ENCORE, INC. DONALD R STONE
K974458 11/25/1997 COMPOLUTE APLICAP ESPE DENTAL-MEDIZIN GMBH & CO.KG. BARBARA WAGNER-SCHUH
K974231 11/12/1997 POSITION PENTA, POSITION PENTA QUICK ESPE GMBH & CO. KG. BARBARA WAGNER-SCHUH
K974299 11/17/1997 PANACRYL ETHICON, INC. GREGORY JONES
K974322 11/17/1997 ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM EUROPA SCIENTIFIC, LTD. ROBERT F MARTIN
K974224 11/10/1997 ENDOLYMPHATIC SAC TO MASTOID T-SHUNT EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K974365 11/19/1997 MILLS INCUS HA SLEEVE EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K974493 11/28/1997 FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH
K974219 11/10/1997 FACEPLATE ASSEMBLY FINETONE HEARING INSTRUMENTS PAUL MENEZES
K974358 11/19/1997 FRIALIT -2 SCREW FRIATEC AG ROBERT SLOMOFF
K974359 11/19/1997 FRIALIT-2 CYLINDER FRIATEC AG ROBERT J SLOMOFF
K974440 11/25/1997 IBI GALLINI U.S., LLC. PAUL L HAWTHRONE
K974355 11/19/1997 INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) GE DEC MEDICAL SYSTEMS TED L PARROT
K974367 11/20/1997 ADVANTX LCN, ADVANTX LCLP GE MEDICAL SYSTEMS LARRY A KROGER
K974399 11/21/1997 BIO-OSS COLLAGEN GEISTLICH-PHARMA PETER S REICHERTZ
K974226 11/12/1997 IMMUNODOT MONO-G TEST GENBIO BRYAN KIEHL
K974244 11/12/1997 IMMUNODOT MONO-M TEST GENBIO BRYAN KIEHL
K974368 11/20/1997 AIMSTICK PBD PREGNANCY GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K974227 11/12/1997 HOSPITAL'S CLAMP GPS LOUIS PAGLIARA
K974228 11/12/1997 HOSPITAL'S SPEC GPS LOUIS PAGLIARA
K974395 11/21/1997 ATLANT'S GRAD-LINE CORP. WALTER L WASSERMAN
K974237 11/12/1997 GSI 70 AUDIOPATH SCREENER GRASON-STADLER, INC. NORMAN L SCHULTZ
K974583 11/18/1997 DEEGLITE GRASS-TELEFACTOR PRODUCT GROUP JAMES S BRYAN
K974232 11/12/1997 ESSENTIAL SHAVER SYSTEM GYRUS ENT L.L.C. DEBORAH A ARTHUR
K974311 11/17/1997 VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT GYRUS ENT L.L.C. ALICIA FARAGE
K974318 11/17/1997 HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS FOR THE LIMB HEALTHCARE SERVICE AND SUPPLY RICK ROEDER
K974453 11/25/1997 NASAL INTERFACE MODEL 7910 HEALTHDYNE TECHNOLOGIES, INC. BETTY CORTELLONI
K974175 11/06/1997 HEARTPORT ENDOAORTIC CLAMP CATHETER HEARTPORT, INC. MARIANNE C DRENNAN
K974390 11/21/1997 GLUMA ONE BOND HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K974420 11/24/1997 M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION HEWLETT-PACKARD CO. STEVEN A CLARKE
K974457 11/25/1997 SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T HEWLETT-PACKARD CO. ROB BUTLER
K974441 11/25/1997 SUNGLASSES HIP SHING FAT CO., LTD. PETER K C. LEE
K974212 11/10/1997 AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES J ROGERS
K974498 11/28/1997 STRATIS II HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES JOCHEN ROGERS
K974168 11/05/1997 COOPERSURGICAL INFRARED COAGULATOR HOGAN & HARTSON JONATHAN S KAHAN
K974334 11/18/1997 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES HONG HUANG TANG INDUSTRIAL CO., LTD. HUAN CHUNG-LI
K974289 11/14/1997 EPI-UNION PLATING SYSTEM HOWMEDICA, INC. VIVIAN KELLY
K974316 11/17/1997 HYDROFERA FEMORAL WICK HYDROFERA, LLC. HEATHER S BOND
K974313 11/17/1997 HYDROFERA SURGICAL SPEAR HYDROFERA, LLC. HEATHER S BOND
K974173 11/05/1997 ERECAID SYSTEM/STAY EREC SYSTEM IMAGYN MEDICAL TECHNOLOGIES, INC. RONALD H BERGESON
K974126 11/03/1997 IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW IMCOR ROBERT S URA
K974463 11/26/1997 IMMUNO CONCEPTS ANCA TEST SYSTEM IMMUNO CONCEPTS, INC. ERIC S HOY
K974478 11/26/1997 IMMUNO CONCEPTS ANCA TEST SYSTEMS IMMUNO CONCEPTS, INC. ERIC S HOY
K974243 11/12/1997 KERATOME SYSTEM INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. CHARLES VASSALLO
K974456 11/25/1997 CMVGEN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K974125 11/03/1997 IL TEST AMYLASE INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K974337 11/18/1997 IL TEST UREA NITROGEN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K974203 11/10/1997 PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM INTEGRATED ORBITAL IMPLANTS, INC. FLOYD G LARSON
K974296 11/17/1997 MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED INVACARE CORP. EDWARD A KROLL
K974369 11/20/1997 APOLLO 9500 ION LASER TECHNOLOGY J. RAYMOND KEMPLE
K974336 11/18/1997 CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. J-LLOYD MEDICAL, INC. JAMES L SKAGGS
K974335 11/18/1997 EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. J-LLOYD MEDICAL, INC. JAMES L SKAGGS SR.
K974376 11/20/1997 JTECH ADJUSTER REFLEX GUN J-TECH MEDICAL, INC. E.J SMITH
K974197 11/07/1997 ELITE LIGHTWEIGHT WHEELCHAIR JAKEN CO., INC. SAMANTHA LIN
K974131 11/03/1997 ALERT JENERIC/PENTRON, INC. MURRAY C GAMBERG
K974331 11/18/1997 UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM JOHNSON & JOHNSON PROFESSIONALS, INC. JANET G JOHNSON
K974195 11/07/1997 FLEXIBLE TIP DIGITAL THERMOMETER K-JUMP HEALTH CO., LTD. ROBERT J ZAPPA
K974366 11/20/1997 KSEA PLASTIC TROCARS KARL STORZ ENDOSCOPY KEVIN KENNAN
K974391 11/21/1997 KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM KARL STORZ IMAGING, INC. TERRY F ERNANDEZ
K974188 11/07/1997 CETYLCIDE-G KELLER AND HECKMAN JOHN S ELDRED
K974415 11/24/1997 KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP KIMBERLY-CLARK CORP. LARRY R KLUDT
K974143 11/03/1997 KMC "NEWSKIN" KMC INTL. CO. CINDIE SHIMM
K974486 11/26/1997 CLEARFIL LINER BOND 2V KURARAY AMERICA, INC. KOJI FUJITA
K974348 11/19/1997 ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING LABORATOIRES URGO S.A. EVAN DICK
K974229 11/12/1997 LS-905 FIBERCHOICE ADAPTER SYSTEM LASER PERIPHERALS LLC. NANCY L ARNOLD
K974139 11/03/1997 LQUET CANNULA/TROCAR SYSTEM LIFEQUEST ENDOSCOPIC TECHNOLOGIES, INC. JEFFREY SCOTT
K974451 11/25/1997 ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. LORI D CONZEN
K974302 11/17/1997 LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B LIGHT DIAGNOSTICS CINDY PENNY
K974460 11/25/1997 LITE TOUCH ERBIUM LASER TREATMENT SYSTEM LORAD CORP. WALLY ORLOW
K974437 11/24/1997 EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE LUNAR CORP. KENNETH D BUROKER
K974233 11/12/1997 LYSONIX IRRIGATION SYSTEM LYSONIX, INC. RONALD F LAGERQUIST
K974254 11/13/1997 BENEFIT B3--- SERIES M.C. HEALTHCARE PRODUCTS, INC. R N THOMPSON
K974446 11/25/1997 MANAN AUTOMATIC CUTTING NEEDLE MANAN MEDICAL PRODUCTS, INC. MICHAEL PLISHKA
K974199 11/10/1997 ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION MARQUETTE MEDICAL SYSTEMS, INC. KRISTIN PABST
K974431 11/24/1997 CHEMO-SPIKE II RECONSTITUTION DEVICE MEDI-DOSE, INC. ROBERT BRAVERMAN
K974236 11/12/1997 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
K974164 11/05/1997 SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE MEDICAL DEVICE CONSULTANTS, INC. ROSINA ROBINSON
K974269 11/13/1997 SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, MEDISON AMERICA, INC. PETER KLEIN
K974174 11/06/1997 ULTRABUR MEDNET LOCATOR, INC. JUDY CHANDLEER
K974308 11/17/1997 MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY MEDRAD, INC. MARY A GREENAWALT
K974438 11/24/1997 MEDRAD ATD-T INTERFACE DEVICE MEDRAD, INC. MARY ANNE GREENWALT
K974163 11/05/1997 MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 MEDTRONIC MINIMED DON SELVEY
K974469 11/26/1997 MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL MENTOR CORP. DONNA A CRAWFORD
K974260 11/13/1997 PYRILINKS-D ASSAY KIT METRA BIOSYSTEMS, INC. DAVID CASAL
K974473 11/26/1997 EASY RIDER MICRO CATHETER MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K974351 11/19/1997 BIOLOG 3000 ELECTROCARDIOGRAPH MICROMEDICAL, INC. MALCOM CASTLE
K974352 11/19/1997 CARDIOVIEW 3000 SOFTWARE MICROMEDICAL, INC. MALCOM CASTLE
K974220 11/12/1997 MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE MICROMEDICAL, INC. MALCOM CASTLE
K974387 11/21/1997 PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE MICROWAVE MEDICAL SYSTEMS, INC. RICHARD S GRABOWY
K974291 11/14/1997 MITEK BTB ABSORBABLE (PLA) CROSS PIN MITEK PRODUCTS EDWARD F KENT
K974341 11/18/1997 MITEK BTB ABSORBABLE (PLA) CROSS PIN MITEK PRODUCTS ROBERT ZOLETTI
K974345 11/19/1997 MITEK KNOTLESS ANCHOR MITEK PRODUCTS EDWARD F KENT
K974414 11/24/1997 MULTI MORNING CALM CORP. ALEXANDER B KIM
K974149 11/04/1997 AMBULATORY X-12 TELEMETRY MODULE MORTARA INSTRUMENT, INC. SCOTT J PEASE
K974385 11/21/1997 MLS ELECTROMYOGRAPHIC PREAMPLIFIER MOTION LAB SYSTEMS, INC. EDMUND CRAMP
K974170 11/05/1997 DUOSTAR MTI CORP./ ELECTROSTAR S.A.-HAITI C. T HARDY
K974172 11/05/1997 SILGEL TOPICAL GEL SHEET NAGOR LTD. J A EVANS
K974297 11/17/1997 GALILEO DISPOSABLE HYSTEROSCOPES NETOPTIX CORP. MARY MCNAMARA-CULLINANE
K974495 11/28/1997 NEUROAMP EEG AMPLIFIER NEUROCORP, LTD. EMIN ERALP
K974292 11/14/1997 NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES NIHON KOHDEN AMERICA, INC. GARY REASONER
K974123 11/03/1997 BRANEMARK SYSTEM DEC 600 DRILLING UNIT NOBEL BIOCARE UAS INC BETSY A BROWN
K974150 11/04/1997 PROCERA PREPARABLE ABUTMENT SYSTEM NOBEL BIOCARE UAS INC BETSY A BROWN
K974310 11/17/1997 NOMOS SLIT COLLIMATOR (BEAK) NOMOS CORP. MARVIN L SUSSMAN
K974321 11/17/1997 HYDROTONE NORTH AMERICAN TECHNICAL SERVICES CORP. RICHARD C LANZILLOTTO
K974428 11/24/1997 DIPSTREAK NOVAMED LTD. GERALD M SLUTZKY
K974444 11/25/1997 NUMASTATION NUMA, INC. KURT N LARSON
K974349 11/19/1997 OHMEDA-OHIO CARE PLUS INCUBATOR OHMEDA MEDICAL ALBERTO F PROFUMO
K974374 11/20/1997 SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV OHMEDA MEDICAL JING ZHANG
K974234 11/12/1997 MICRO-PLATE COTININE EIA ORASURE TECHNOLOGIES, INC. SAM R NIEDBALA
K974464 11/26/1997 ORATEC SPINECATH INTRADISCAL CATHETER ORATEC INTERVENTIONS, INC. MICHAEL KWAN
K974200 11/10/1997 ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM ORCA DIAGNOSTICS CORP. SHEILA W PICKERING
K974158 11/03/1997 ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY ORTHO DEVELOPMENT CORP. CAROL FRASIER
K974406 11/21/1997 ORTHOPLAN ORTHO-GRAPHICS, INC. PETER M STEVENS
K974186 11/07/1997 ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING ORTHOFIX SRL ROBERT L SHERIDAN
K974434 11/24/1997 OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS OSTEONICS CORP. TERRY S HERIDAN
K974394 11/20/1997 ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K974443 11/25/1997 POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED P.T. LATEXINDO TOBAPERKASA HENDRA RAMALI
K974442 11/25/1997 PRE-POWDERED NITRILE EXAMINATION GLOVES P.T. LATEXINDO TOBAPERKASA HENDRA RAMALI
K974362 11/19/1997 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K974285 11/14/1997 PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT PERIMED, INC. KJELL BAKKEN
K974501 11/28/1997 DIGITAL TINNITUS MASKING SYSTEM PETROFF AUDIO TECHNOLOGIES MICHAEL L PETROFF
K974350 11/19/1997 ALLERGAN IMMUNO CAP M4, M8, K70 PHARMACIA, INC. KAREN E MATIS
K974180 11/06/1997 STERI-TAMP PHARMACY, INC. ED RANSOM
K974207 11/10/1997 PHILIPS EASYVISION WORKSTATION PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K974287 11/14/1997 FM RECEIVER - AUDITORY TRAINER PHONIC EAR, INC. ROBERT L REINKE
K974327 11/18/1997 WINGED NEEDLE HOLDER PHX TECHNOLOGIES CORP. JAMES F CHAPEL, PH.D.
K974250 11/13/1997 VERSASTAT MULTIPOLAR SCISSORS AND CABLES PILLING WECK, INC. RICHARD G JONES
K974409 11/24/1997 FRIEDL GLIDING NAIL SYSTEM PLUS ORTHOPEDICS HARTMUT LOCH
K974466 11/26/1997 BOSTON ADVANCE CLEANER POLYMER TECHNOLOGY CORP. DOGULAS J FORTUNATO
K974181 11/06/1997 ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B PRINCETON BIOMEDITECH CORP. JEMO KANG
K974425 11/24/1997 BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST PRINCETON BIOMEDITECH CORP. JEMO KANG
K974202 11/10/1997 PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS PULPDENT CORP. KENNETH J BERK
K974398 11/21/1997 PULPDENT CAVITY VARNISH PULPDENT CORP. KENNETH J BERK
K974210 11/10/1997 SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 RAD-SOURCE, INC. RANDOL E KIRK
K974326 11/18/1997 LATEX CONDOMS (NATURAL COLOUR) REDDY MEDTECH HEALTH PRODUCTS LTD. RAVI REDDY
K974324 11/18/1997 LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT REDDY MEDTECH HEALTH PRODUCTS LTD. RAVI REDDY
K974323 11/18/1997 LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT REDDY MEDTECH HEALTH PRODUCTS LTD. RAVI REDDY
K974417 11/24/1997 SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM RESMED CORP. SCOTT DUDEVOIR
K974257 11/13/1997 RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) RESOUND CORP. KRISTA M BUCKLES
K974503 11/28/1997 ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC. ALEX WESOLOWSKI
K974342 11/18/1997 ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC. ALEX WESOLOWSKI
K974129 11/03/1997 HI-69E, HI-69N, HI-69P ROCKWIN CORP. KEITH TAYLOR
K974419 11/24/1997 RUSCH SIMPLASTIC COUNCILL TIP CATHETER RUSCH, INC. RONALD J YOUNG
K974154 11/04/1997 CHOICE ACCU-TEST PREGNANCY TEST KIT SA SCIENTIFIC, INC. HARBI SHADFAN
K974306 11/17/1997 SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA SANGUI BIOTECH, INC. JOHN J KIANG
K974354 11/19/1997 MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE SCA MOLNLYCKE MIGUEL A NEGRON
K974262 11/13/1997 SYSCOS IDC - G, IDC, BSC, IDC - G SCANTIBODIES LABORATORY, INC. RICHARD LENART
K974141 11/03/1997 PLUS REUSABLE RESUSCITATOR SCHIFF & CO. ANNE M CESARIO
K974253 11/13/1997 CPD COMMANDER SCIERAN TECHNOLOGIES, INC. ROD ROSS
K974241 11/12/1997 SCIMED INFORMER PRESSURE WIRE SYSTEM SCIMED LIFE SYSTEMS, INC. JILL TOWNSEND
K974303 11/17/1997 INFANT FLOW SYSTEM SENSORMEDICS CORP. PAUL L KITTINGER
K974151 11/04/1997 VINYL PATIENT EXAMINATION GLOVES (POWDERED) SHANGHAI SUPER GLOVES CO., LTD. SUSAN D GOLDSTEIN-FALK
K974492 11/28/1997 SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS SIEMENS MEDICAL SOLUTIONS USA, INC. JACQUELINE E M. EMERY
K974480 11/26/1997 SILIMED CALF IMPLANT SILIMED, LLC. E J SMITH
K974482 11/26/1997 SILIMED GLUTEAL IMPLANT SILIMED, LLC. E J SMITH
K974479 11/26/1997 SILIMED VAGINAL STENT SILIMED, LLC. E J SMITH
K974471 11/26/1997 PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A SIMS DELTEC, INC. LISA STONE
K974372 11/20/1997 AIR OXYGE MIXER SK MED DIPAK GHOSH
K974209 11/10/1997 SILICONE TISSUE/INFLATABLE TISSUE EXPANDER SPECIALTY SURGICAL PRODUCTS, INC. JAN VARNER
K974184 11/06/1997 HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K974185 11/06/1997 POLYMER NITRILE EXAMINATION GLOVES SRI JOHANI SDN. BHD. LIM LEE AIK
K974183 11/06/1997 POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K974182 11/06/1997 POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K974134 11/03/1997 X-SIGHT DIGITAL IMAGING SYSTEM STALLION TECHNOLOGIES, INC. MARSHALL MA
K974429 11/24/1997 RAPET CRP STANBIO LABORATORY KIRK JOHNSON
K974370 11/20/1997 RAPET RF STANBIO LABORATORY KIRK JOHNSON
K974346 11/19/1997 STARLIGHT PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K974423 11/24/1997 ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL STERLING DIAGNOSTIC IMAGING, INC. JEAN E BARLETT
K974206 11/10/1997 SYNTHES CRANIAL SPRING CLIP (CSC) SYNTHES (USA) SHERI MUSGNUNG
K974485 11/26/1997 SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION SZABOCSIK AND ASSOC. JOHN M SZABOCSIK
K974179 11/06/1997 NON-PRESCRIPTION SUNGLASSES TAIPAN OPTICAL COMPANY LTD. HENRY HSU
K974312 11/17/1997 REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR TELEMED SYSTEMS, INC. SAMUEL D WADE
K974300 11/17/1997 TELEMED SYSTEMS RETRIEVAL BASKET TELEMED SYSTEMS, INC. SAMUEL D WADE
K974307 11/17/1997 RTR-2000/RTR-4000 TERARECON, INC. TIM FRANDSEN
K974171 11/05/1997 COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS TEVA MEDICAL, LTD. HARRY LEINWAND
K974280 11/05/1997 ABUTMENT - COMPLETE THE IMPLANT CENTER OF THE PALM BEACHES JACK T KRAUSER
K974208 11/10/1997 TYTRON C-3000 TITRONICS RESEARCH & DEVELOPMENT CO. JOSEPH R TITONE
K974286 11/14/1997 CIRCUMCISION TRAY, CAT. NO. 70340 TRINITY LABORATORIES, INC. PARTHA BASUMALLIK
K974238 11/12/1997 DENTAL TRAY, STERILE, DISPOSABLE TRINITY LABORATORIES, INC. PARTHA BASUMALLIK
K974454 11/25/1997 CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 TUCSON MEDICAL CORP. JIM PATKO
K974413 11/24/1997 PERMAFLO ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K974283 11/14/1997 PQ 1 ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K974282 11/14/1997 VITALESCENCE ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K974432 11/24/1997 ULTRAGUIDE 1000 ULTRAGUIDE LTD. GEORGE H MYERS
K974213 11/10/1997 AURORA TITANIUM SPINAL ROD SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SHARON MURPHY
K974338 11/18/1997 UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) UNITRON INDUSTRIES, INC. SUSAN ARCHER
K974339 11/18/1997 UNITRON MODEL SOUND F/XD PROGRAMMABLE UNITRON INDUSTRIES, INC. SUSAN ARCHER
K974340 11/18/1997 UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE UNITRON INDUSTRIES, INC. SUSAN ARCHER
K974137 11/03/1997 UROMED NEEDLE GRASPER UROMED CORP. FREDERICK TOBIA
K974402 11/21/1997 3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT VANCOUVER IMPLANT RESOURCES, INC. HAROLD BERGMAN
K974403 11/21/1997 3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT VANCOUVER IMPLANT RESOURCES, INC. HAROLD BERGMAN
K974404 11/21/1997 4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT VANCOUVER IMPLANT RESOURCES, INC. HAROLD BERGMAN
K974401 11/21/1997 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT VANCOUVER IMPLANT RESOURCES, INC. HAROLD BERGMAN
K974290 11/14/1997 MICROPROTEIN STANDARD KIT VERICHEM LABORATORIES, INC. ANTHONY J DIMONTE
K974215 11/10/1997 VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET VETCO, INC. JEFF SHAPIRO
K974315 11/17/1997 VIDAR VXR LS LASER FILM DIGITIZER VIDAR SYSTEMS CORP. BILLY STAMPER
K974319 11/17/1997 MIGHTY AIR WHEELCHAIRS OF KANSAS LEE FRICKEY
K974169 11/05/1997 WIELISA ANTI-GBM TEST SYSTEM WIESLAB AB WILLIAM L BOTELER
K974166 11/05/1997 WIELISA MPO ANCA TEST SYSTEM WIESLAB AB WILLIAM L BOTELER
K974167 11/05/1997 WIELISA PR-3 ANCA TEST SYSTEM WIESLAB AB WILLIAM L BOTELER
K974328 11/18/1997 ADVANCE TOTAL KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. KIM TOMPKINS
K974435 11/24/1997 MICHELSON ANTERIOR CERVICAL PLATE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. DAN REGAN
K974240 11/12/1997 LIGHTLINE-M WUESTEC MEDICAL, INC. KRISTI WHITE
K974484 11/26/1997 ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE XIMED/PROSURE/INJECTX ASHVIN DESAI
K974251 11/13/1997 X-CELL WOUND DRESSING XYLOS CORPORATION ERIC FLAM
K974191 11/10/1997 EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE YTY INDUSTRY (MANJUNG) SDN. BHD. MOH UNG NANG
K974288 11/14/1997 ZEROWET SPLASHIELD ZEROWET, INC. KEITH STAMLER


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