FDA 510(k) Applications Received During October, 1997

FDA 510(k) Number Submission Date Device Name Applicant Contact
K973926 10/15/1997 O BUTMENT HS IMPLANT "O" CO., INC. DAVID D DALISE
K973899 10/14/1997 UNIFINE PENTIPS *OWNE MUMFORD USA, INC.** ROBERT E SHAW
K973961 10/16/1997 3M DENT SYSTEM II PLUS 3M COMPANY LAEL J PICKETT
K974032 10/23/1997 ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR A & A MEDICAL, INC. JIHAD MANSOUR
K974038 10/24/1997 THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT A & A MEDICAL, INC. JIHAD MANSOUR
K974103 10/31/1997 ABBOTT AXSYM TROPONIN-I ABBOTT LABORATORIES LAURA L GRANITZ
K973811 10/07/1997 POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED) ABSOLUTE QUALITY LEADERSHIP, INC. DONNA DI GANGI
K973767 10/02/1997 HARMONIC IMAGING WITH CONTRAST ACUSON CORP. WILLIAM WELCH
K973981 10/20/1997 SAFEPASS STERILIZATION POUCH ADROIT MEDICAL SYSTEMS, INC. RICHARD L STUDER
K974010 10/21/1997 ADVANTAGE EMG SYSTEM, MODEL #A100 ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX ROBERT SNOW
K973736 10/01/1997 AESCULAP HILAN MOTOR SYSTEM AESCULAP, INC. MARY E HOLDEN
K973953 10/16/1997 AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
K973967 10/17/1997 AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) ALDEN OPTICAL LABS., INC. MARTIN DALSING
K973850 10/08/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 ALEXANDER MFG. CO. KEN HEIMENDINGER
K973851 10/08/1997 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 ALEXANDER MFG. CO. KEN HEIMENDINGER
K974061 10/27/1997 RECHARGEABLE BATTERY PART NUMBER GL825-200 ALEXANDER MFG. CO. KEN HEIMENDINGER
K974027 10/23/1997 AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK ALFA BIOTECH (UK) LTD. M. JOHN TAYLOR
K973770 10/02/1997 ALLEGIANCE KWIK HEAT WARM PERINEAL PACK ALLEGIANCE HEALTHCARE CORP. PATRICIA SHARPE-GREGG
K973873 10/10/1997 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 AMERICAN TELECARE, INC. GERARD J PRUD'HOMME
K973957 10/16/1997 DBEST ONE-STEP HCG SERUM/URINE TEST AMERITEK, INC. K C YEE
K974042 10/24/1997 AMSURE CLEANSING ENEMA SET AMSINO INTL., INC. RICHARD Y LI
K974045 10/24/1997 VENNETO AMSURE SPORTS, INC. WENDY W.C. SIU
K973980 10/20/1997 ACU-STIM TENS, AP-101082T APEX MEDICAL CORP. DANIEL LEE
K973978 10/20/1997 MICRO II MICROCURRENT TENS APEX MEDICAL CORP. DANIEL LEE
K973979 10/20/1997 MULTI-STIM TENS, AP-101081T APEX MEDICAL CORP. DANIEL LEE
K973891 10/14/1997 LAPAROSCOPIC GASTROSTOMY KIT APPLIED MEDICAL RESOURCES HOWARD V ROWE
K973893 10/14/1997 AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE APPLIED MEDICAL TECHNOLOGIES THOMAS W PARKINSON
K973950 10/16/1997 RETINAL CUBE APPLIED SPECTRAL IMAGING, LTD. MICHAEL ADEL
K973812 10/07/1997 ARTHREX PUDDU OSTEOTOMY SYSTEM ARTHREX, INC. SCOTT M DURLACHER
K973872 10/10/1997 ATRION MEDICAL COATED LACRIMAL INTUBATION SET ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K973741 10/01/1997 BAIR HUGGER BLOOD/FLUID WARMER AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K973829 10/07/1997 IRRIGATION BOTTLE AUTOMATIC LIQUID PACKAGING, INC. JOHN BRDA
K973760 10/02/1997 AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE AVECOR CARDIOVASCULAR, INC. DENNIS E STEGER
K973846 10/08/1997 AIR CONDUCTION HEARING AID BARON TRADING, INC. PHILLIP RECHISTER
K973921 10/15/1997 BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K974006 10/21/1997 BECTON DICKINSON TWINPAK BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREG MORGON
K973743 10/01/1997 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC. MICHELE Z BURTNESS
K973966 10/17/1997 ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC. SHELLIE GUST
K974075 10/29/1997 ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN INSTRUMENTS, INC. JAN OLSEN
K973932 10/15/1997 BECKMAN CALIBRATOR 2 (CAL2) BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K973928 10/15/1997 BECKMAN URINE PROTEIN CALIBRATOR (UCAL) BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K974110 10/31/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K973813 10/07/1997 IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K974050 10/24/1997 SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K973832 10/07/1997 OPUS HLH CONTROLS BEHRING DIAGNOSTICS, INC. Ruth Forstadt
K973948 10/16/1997 DUALINE 100 BTE BERNAFON-MAICO, INC. RAY ENROTH
K974069 10/28/1997 OPUS 2 - CANAL SERIES (ITC) BERNAFON-MAICO, INC. RAY ENROTH
K974106 10/31/1997 ICON IMPLANT SYSTEM BIO SCIENCE TECHNOLOGIES, INC. ALAN DONALD
K973883 10/14/1997 BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K974076 10/29/1997 SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K973857 10/09/1997 FLOSTAT VASCULAR REPORT GENERATOR (VRG) BIOMEDIX, INC. DAVID LERNER
K973819 10/07/1997 VIDAS D-DIMER (DD) ASSAY BIOMERIEUX VITEK, INC. TERRY MCGOVERN
K973775 10/03/1997 HARPOON SUTURE ANCHORS BIOMET, INC. MARY VERSTYNEN
K973784 10/03/1997 TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS BIOSITE INCORPORATED JOHN F BRUNI
K973922 10/15/1997 ARCHIMED 4210 AND 4220 BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K974079 10/29/1997 FORMULA FOR ARCHIMED BIOSOUND ESAOTE, INC. COLLEEN HITTLE
K974097 10/30/1997 PERIACRYL BLACKLOCK MEDICAL PRODUCTS, INC. DON BLACKLOCK
K973973 10/20/1997 ELECSYS CALLCHECK DIGOXIN BOEHRINGER MANNHEIM CORP. JODY J SAVAGE
K973788 10/06/1997 MICROVASIVE LIPTHOTRIPSY PROBES BOSTON SCIENTIFIC CORP. CAROL J HOLLOWAY
K973826 10/07/1997 SPHINCTEROTOME BOSTON SCIENTIFIC CORP. DANIEL J DILLON
K973818 10/07/1997 T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. JOCELYN KERSTEN
K973962 10/16/1997 BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS C.R. BARD, INC. SANDRA PERREAND
K974638 10/10/1997 STERITITE SEALED CONTAINERS MODEL SCO4Q CASE MEDICAL, INC. LARRY R PILOT
K973839 10/08/1997 DISPOSABLE ESOPHAGEAL STETHOSCOPE CATHETER RESEARCH, INC. JOHN A STEEN, PH.D.
K973776 10/03/1997 REFLECTIONS CDB CORP. SYLVIA C JOYCE
K974029 10/23/1997 ACS TOBRAMYCIN CHIRON DIAGNOSTICS CORP. THOMAS F FLYNN
K973820 10/07/1997 USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE CIRCON CORP. ANDREW D SIMONS
K973746 10/01/1997 PRE-FILLED SYRINGE FOR KOALA IUP CLINICAL INNOVATIONS, INC. DEAN WALLACE
K974085 10/29/1997 COBE OXYGENATOR PRODUCTS COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K973936 10/15/1997 FOCUS RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K973860 10/09/1997 OVULON MONITOR CONCEPTION TECHNOLOGY, INC. TERRY R KNAPP, MD
K974028 10/23/1997 STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING CONCEPTUS, INC. CONNIE ACUFF
K973890 10/14/1997 UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE CONMED CORP. IRA D DUESLER, JR
K973806 10/06/1997 DUODERM HYDROACTIVE GEL CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K973807 10/06/1997 DUODERM HYDROACTIVE PASTE CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K973845 10/08/1997 CORDIS HYDRONOL STEERABLE GUIDEWIRE CORDIS CORP. JACQUELINE ZIMOVAN
K973836 10/08/1997 SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM CROSS MEDICAL PRODUCTS, INC. PHIL MELLINGER
K973974 10/20/1997 DADE TRU-LIQUID CARDIAC CONTROL DADE INTL., INC. BETTY HERNANDEZ-LABADIE
K973840 10/08/1997 FAST-CATH (TM) INTRA-CARDIAC INTRODUCER DAIG CORP. DEAN BRUHN-DING, RAC
K973954 10/09/1997 IMAGEN RESPIRATORY SCREEN DAKO DIAGNOSTICS LTD. ELISABETH SILVER
K974114 10/31/1997 DASH, VITAL GARD DASH MEDICAL GLOVES SDN BHD ROBERT J SULLIVAN
K973985 10/20/1997 AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) DATEX-ENGSTROM, INC. JOEL KENT
K974101 10/30/1997 DATEX-ENGSTROM NETWORK DATEX-ENGSTROM, INC. JOEL KENT
K974015 10/22/1997 ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL DAVIS & GECK, INC. STEPHEN J TAMSETT
K974057 10/27/1997 DENTEK LD 15 LASERSYSTEM DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. ROBERT W BAUER
K973781 10/03/1997 AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFREY LEHN
K973782 10/03/1997 AQUASIL XLV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFREY LEHN
K974035 10/24/1997 CENTURY ALLOY DENTSPLY INTL. P. JEFFERY LEHN
K974044 10/24/1997 GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. ARLENE C SAULL
K974117 10/31/1997 PELVX DONUT, PELVX CUBE DESCHUTES MEDICAL PRODUCTS, INC. MATTHEW W HOSKINS
K974116 10/31/1997 PELVX INCONTINENCE RING DESCHUTES MEDICAL PRODUCTS, INC. MATTHEW W HOSKINS
K974115 10/31/1997 PELVX RING, PELVX RING WITH SUPPORT DESCHUTES MEDICAL PRODUCTS, INC. MATTHEW W HOSKINS
K974003 10/21/1997 ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K974053 10/27/1997 AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K974001 10/21/1997 ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K973999 10/21/1997 CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K974002 10/21/1997 ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K973933 10/15/1997 SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K973931 10/15/1997 UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K974000 10/21/1997 Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K973810 10/07/1997 DRG LARGE SCREW SYSTEM DOLPHIN MEDICAL TECHNOLOGIES, INC. MARK G URBANSKI
K973949 10/16/1997 PERIOPERATIVE DATA MANAGEMENT SYSTEM DRAEGER MEDICAL, INC. JAMES J BRENNAN
K973757 10/02/1997 D.O.R.C. SOLUX LIGHT SOURCE DUTCH OPHTHALMIC USA, INC. MARK W FURLONG
K973833 10/07/1997 CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL DYNARAD CORP. RAYMOND MANEZ
K974086 10/29/1997 KODAK DIGITAL SCIENCE CARDIAC VIEWER EASTMAN KODAK COMPANY MARK SMITH
K974107 10/31/1997 KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) EASTMAN KODAK COMPANY NANCY BUTCHER
K973923 10/15/1997 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM EBI ELECTRO BIOLOGY JON CAPAROTTA
K973934 10/15/1997 SUNGLASSES ELEGANCE OPTICAL MANUFACTORY, LTD. ESTER LAI
K973809 10/06/1997 FOUNDATION FRACTURE STEM ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K974095 10/30/1997 FOUNDATION POROUS COATED FLARED RIM SHELL ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K974093 10/30/1997 FOUNDATION POROUS COATED HEMISPHERICAL SHELL ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K973803 10/06/1997 FLEXVIEW CO2 BLOWER WITH MIST ETHICON ENDO-SURGERY, INC. LORRI CHAVEZ
K974098 10/30/1997 PUBOUURETHRAL SLING ETHICON, INC. GREGORY R JONES
K973998 10/21/1997 VINYL PATIENT EXAMINATION GLOVES POWDER-FREE EVERRISE GLOVE PRODUCTS CO., LTD. JASON CHANG
K973902 10/14/1997 VINYL PATIENT EXAMINATION GLOVES POWDERED EVERRISE GLOVE PRODUCTS CO., LTD. JASON CHANG
K974008 10/17/1997 PFLEIDERER'S INTRATYMPANIC CATHETER EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K974007 10/21/1997 SHAH PERMAVENT EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K973756 10/02/1997 EYE SYS VISTA EYESYS TECHNOLOGIES, INC. BETH A SOPER
K973884 10/14/1997 ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE FRANTZ DESIGN, INC. DONALD FRANTZ
K974090 10/29/1997 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS FRESENIUS MEDICAL CARE NORTH AMERICA TOM FOLDEN
K973924 10/15/1997 FRIOS BONESHIELD FRIATEC AG ROBERT J SLOMOFF
K973844 10/08/1997 GASTRIC AND RECTAL CATHETERS G & J ELECTRONICS, INC. SAM JUNDLER
K973941 10/15/1997 IMMUNOWELL EBNA IGG TEST GenBio Bryan Kiehl
K973940 10/15/1997 IMMUNOWELL EBV VCA IGG TEST GenBio Bryan Kiehl
K973939 10/15/1997 IMMUNOWELL VCA IGM TEST GenBio Bryan Kiehl
K973910 10/14/1997 GLIADIN ANTIBODIES ELISA GENESIS DIAGNOSTICS LTD. MICHAEL WALKER
K973825 10/07/1997 MIDSTREAM HOME REGNANCY TEST GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K974084 10/29/1997 GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT GETINGE/CASTLE, INC. TREVOR WILLIAMSON
K973871 10/10/1997 LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) HARTALEGA SDN BHD KUAN KAM HON
K973778 10/03/1997 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES HARTALEGA SDN BHD KAM H KUAN
K973823 10/07/1997 PR 3 ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC. JOSEPH CALIFANO
K973822 10/07/1997 VIRGO ANCA SCREEN KIT HEMAGEN DIAGNOSTICS, INC. JOSEPH M CALIFANO
K973824 10/07/1997 VIRGO PANCO KIT HEMAGEN DIAGNOSTICS, INC. JOSEPH M CALIFANO
K973955 10/16/1997 HERNIAMESH SURGICAL MESHES HERNIAMESH LORENA A TRABUCCO
K974087 10/29/1997 MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT HEWLETT-PACKARD CO. RAY STELTING
K973863 10/09/1997 MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR HI-TRONICS DESIGNS, INC. JACQUES P SCHWARTZ
K973849 10/08/1997 BIOABSORBABLE BANKART TACK HOGAN & HARTSON JONATHAN S KAHAN
K974048 10/24/1997 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER HOLLISTER, INC. JOSEPH S TOKARZ
K974058 10/27/1997 FS IV MINI C-ARM SYSTEM HOLOGIC, INC. Nandini Murthy
K974056 10/27/1997 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP HOLOPACK INTERNATIONAL, LP JOHN J BARTHE
K974054 10/27/1997 DISTAL CENTRALIZER, EXETER II HIP SYSTEM HOWMEDICA, INC. FRANK MAAS
K973982 10/20/1997 ORBITAL RECONSTRUCTION PLATES HOWMEDICA, INC. VIVIAN KELLY
K973927 10/15/1997 HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL HYUNJAE CORP. DAN MODICA
K973771 10/02/1997 DENTAL/SURGICAL DRILLS, BURS, TAPS IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K974074 10/29/1997 INFUSION DYNAMICS POWER INFUSER INFUSION DYNAMICS, INC. THOMAS BECZE
K973874 10/10/1997 ACL CLIP-IN PLATE INNOVASIVE DEVICES, INC. ERIC BANNON
K974049 10/24/1997 INNOVASIVE LINX BT 10MM LIGAMENT FASTENER INNOVASIVE DEVICES, INC. STEPHEN PAGE
K973855 10/09/1997 IT HYDROCOLLOID WITH ZINC INNOVATIVE TECHNOLOGIES LTD. PRISCILLA WHITEHEAD COX
K973755 10/02/1997 PILOT TUBE REPAIR KIT INSTRUMENTATION INDUSTRIES, INC. EDWARD C HOREY, JR.
K974060 10/27/1997 MINISTRIP/ SERUM AND URINE COMBO HCG TEST INTERNATIONAL NEWTECH DEVELOPMENT, INC. BENNY WANG
K974059 10/27/1997 ONE STEP MIDSTREAM HCG PREGNANCY TEST INTERNATIONAL NEWTECH DEVELOPMENT, INC. BENNY WANG
K974009 10/21/1997 PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG INTERNATIONAL NEWTECH DEVELOPMENT, INC. BENNY WANG
K974077 10/29/1997 VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. J. MORITA USA, INC. TERRY G MAHN
K973881 10/14/1997 PROSPECTOR PLUS (CODE NAME : RD-0508) J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K974119 10/31/1997 DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) JACK'S ELECTRODES ANTHONY FENDER
K974080 10/29/1997 CRITIKON SOFT BLOOD PRESSURE CUFF JOHNSON & JOHNSON MEDICAL, INC. DARLENE T KORAB
K973774 10/03/1997 CODMAN HAKIM MICRO PRECISION VALVE JOHNSON & JOHNSON PROFESSIONALS, INC. JANET G JOHNSON
K974088 10/30/1997 CODMAN INTRACRANIAL BOLT JOHNSON & JOHNSON PROFESSIONALS, INC. JAMES M FLAHERTY JR.
K973909 10/14/1997 KSEA ENDOTIP SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K973876 10/10/1997 PROPHYFLEX 2, MODEL 2012 KAVO AMERICA GREGORY W BOWMAN
K973915 10/14/1997 INFLATABLE POSITIONING CUSHIONS KCI NEW TECHNOLOGIES, INC. JUDITH A HARBOUR
K973763 10/02/1997 KENDALL CURITY IODOFORM PACKING STRIP KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH DAVID A OLSON
K973827 10/07/1997 KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION KIMBERLY-CLARK CORP. LARRY K LUDT
K973797 10/06/1997 BREATHING CIRCUIT BACTERIAL FILTER KING SYSTEMS CORP. BRUCE E GREEN
K973901 10/14/1997 17 B-ESTRADIOL (ELISA) KMI DIAGNOSTICS, INC. MARK A KOWAL
K973897 10/14/1997 DHEA-S KMI DIAGNOSTICS, INC. MARK A KOWAL
K973898 10/14/1997 PROGESTERONE ELISA KMI DIAGNOSTICS, INC. MARK A KOWAL
K973900 10/14/1997 TESTOTERONE ELISA KMI DIAGNOSTICS, INC. MARK A KOWAL
K973853 10/08/1997 KOLPLAST VAGINAL SPECULUM KOLPLAST COMERCIAL E INDUSTRIAL LTDA E J SMITH
K974089 10/29/1997 ALLOY PRIMER KURARAY AMERICA, INC. KEJI FUJITA
K974004 10/21/1997 AUTOMATED DISPOSABLE KERATOME (ADK) LASERSIGHT TECHNOLOGIES, INC. CHARLES STEWART
K973951 10/16/1997 LEVO COMPACT-EASY LCE LEVO USA THOMAS RAEBER
K973758 10/02/1997 BIOSCREW ABSORBABLE INTERFERENCE SREW LINVATEC CORP. CAROL A WEIDEMAN
K973861 10/09/1997 FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 MAGNATONE HEARING AID CORP. DON E K. CAMPBELL
K973984 10/20/1997 RAC 2A MODULE HOUSING MARQUETTE MEDICAL SYSTEMS, INC. DIANNE SCHMITZ
K973847 10/08/1997 AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS MARTIN DALSING MARTIN J DALSING
K973887 10/14/1997 MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K973986 10/20/1997 MECTEST MECO INDUSTRIES EUGENE A ESGNERRA
K973919 10/15/1997 CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) MEDENTAL INTL. DEBRA GILLASPY
K973865 10/06/1997 BIRTCHER UV LAMP MEDFAXX, INC. BOB JOHNSON
K973970 10/17/1997 SPO2 FINGER PROBES MEDICAL CABLES, INC. CHRISTOPHER J FONTANA
K973888 10/14/1997 SMARTLOCK SAFETY SYRINGE MEDICAL INNOVATION LTD. DANIEL A KRACOV
K974034 10/23/1997 PORTABLE INTENSIVE CARE UNIT MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K973787 10/06/1997 MEDRAD 1.5T EXTREMITY ARRAY MEDRAD, INC. MARY A GREENAWALT
K974062 10/27/1997 MEDSCI 3% GLUTARALDEHYDE MEDSCI, INC. ROBERT MCINTOSH JR.
K973842 10/08/1997 CARBON FIBER CONFORMAL COUCH TOP MEDTEC, INC. DONALD F RIIBE
K974067 10/27/1997 FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. DENNIS REIGLE
K973991 10/21/1997 METRON QA-510 SPO2 ANALYZER METRON U.S., INC. E.J. Smith
K973761 10/02/1997 MICRO-STRIP FOR OPIATE METABOLITES MICRODIAGNOSTICS, INC. ROY CHUNG
K974066 10/27/1997 RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS MICROLINE PENTAX, INC. HUGHES DE LAFORCADE
K973765 10/02/1997 BIO-2000 MICRYLIUM LABORATORIES THAD J OVERMYER, DMD
K973800 10/06/1997 23:1 REDUCTION ANGLE MIDWEST DENTAL PRODUCTS CORP. ROBERT E BOOTH
K974022 10/14/1997 VAPR MITEK PRODUCTS EDWARD F KENT
K974102 10/31/1997 MILTRA IMAGING INC., IMAGE VAULT MITRA IMAGING, INC. GARY J ALLSEBROOK
K973963 10/16/1997 120 LEAF MULTILEAF COLLIMATOR MITSUBISHI ELECTRONICS AMERICA, INC. T W ATHEY
K973916 10/14/1997 NP MEDICAL CAPLESS LUER ACTIVATED VALVE N.P. MEDICAL, INC. PAUL A CARACCIOLO
K974047 10/24/1997 ACCUWELL PHENYLALANINE ASSAY NEOMETRICS, INC. DAVID SCHWARTZ
K973929 10/15/1997 NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM NEOTONUS, INC. JAMES R VEALE
K973740 10/01/1997 ROUND WINDOW E-CATH NEURO-BIOMETRIX, INC. MICHAEL H ARENBERG
K973764 10/02/1997 TEMPERATURE DIAGNOSTIC ACCESSORY NEW STAR LASERS, INC. DAVE HENNINGS
K973828 10/07/1997 PRIMA KTP LASER SYSTEM NIDEK, INC. KEN KATO
K973918 10/15/1997 NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC. GARY REASONER
K973789 10/06/1997 NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC NORIAN CORP. SUSANNE T SMITH
K973848 10/08/1997 IBU, INTEGRATED BRACHY THERAPY UNIT NUCLETRON CORP. RALPH E SHUPING
K973786 10/06/1997 NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE NW RADIATION THERAPY PRODUCTS TERENCE ELLARD
K974083 10/29/1997 CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS OHMEDA MEDICAL JING ZHANG
K973896 10/14/1997 OHMEDA EXCEL 3000 ANESTHESIA SYSTEM OHMEDA MEDICAL CHARLES MORREALE
K973959 10/16/1997 OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE OLICON IMAGING SYSTEMS, INC. HERMAN OOSTERWIJCK
K973793 10/06/1997 OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE OLICON IMAGING SYSTEMS, INC. HERMAN OOSTERWIJCK
K973750 10/01/1997 STC CANNABINOIDS MICRO-PLATE EIA ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K973944 10/16/1997 ORTHOFIX FEMORAL NAILING SYTEM ORTHOFIX SRL ROBERT L SHERIDAN
K973868 10/10/1997 SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) OSTEOTECH, INC. CHRISTOPHER TALBOT
K973886 10/14/1997 OTICON DIGISOUND COMPACT OTICON, INC. PREBEN BRUNVED
K973885 10/14/1997 OTICON DIGISOUND ITE OTICON, INC. PROBEN BRUNVED
K973976 10/20/1997 EPIC-FLO PARKELL, INC. NELSON J GENDUSA
K973864 10/09/1997 COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO PAUSCH CORP. KENNETH J H. RICE
K973834 10/08/1997 CS2000 & CS2000 TOMO PAUSCH CORP. KENNETH TICE
K973972 10/20/1997 PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER) PERFECT EAR DON CAMPBELL
K974082 10/29/1997 THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE PERFORMANCE PLUS, INC. CAROLANN KOTULA
K973835 10/08/1997 PHILIPS EASYVISION WORKSTATION PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K973983 10/20/1997 PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K974096 10/30/1997 CRX DIAMOND VALVE PHOENIX BIOMEDICAL CORP. DAVID KUNIN
K974070 10/28/1997 PHYSIO/1000 PHYSIO DESIGNS, INC. JAMES M TERRACCIANO
K974016 10/22/1997 CERCLAGE CABLE WITH HEX BUTTON PIONEER SURGICAL TECHNOLOGY BURNS O SEVERSON
K973958 10/16/1997 GENERAL PURPOSE ATL NEEDLE GUIDE KIT PROTEK MEDICAL PRODUCTS, INC. RICK L PRUTER
K974014 10/22/1997 PULPDENT DENTASTIC UNO PULPDENT CORP. KENNETH J BERK
K973913 10/14/1997 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE PWA INDUSTRIES SDN. BHD. AZMAN ISMAIL
K973780 10/03/1997 PERSONAL LUBRICATING LIQUID QUALIS, INC. MARY A FINN
K973894 10/14/1997 IMMUSURE QUANTIMETRIX CORP. EVY JOHNSON
K973858 10/09/1997 CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO QUIDEL CORP. Robin Weiner
K973841 10/08/1997 QUICKVUE ONE-STEP HCG-COMBO QUIDEL CORP. ROBING WEINER
K974052 10/27/1997 QUICKVUE SEMI-Q HCG-COMBO QUIDEL CORP. Robin Weiner
K974111 10/31/1997 QUIDEL CH50 EQ EIA QUIDEL CORP. Robin Weiner
K974108 10/31/1997 SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) QUIDEL CORP. EDWARD J MCMULLEN
K973995 10/21/1997 RANDOX BILIRUBIN RANDOX LABORATORIES, LTD. P ARMSTRONG
K973993 10/21/1997 RANDOX CREATININE RANDOX LABORATORIES, LTD. P ARMSTRONG
K973988 10/21/1997 RDI HOMOGENEOUS HDL CHOLESTEROL TEST REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K974380 10/21/1997 REJUVENESS REJUVENESS PHARAMCEUTICALS, INC. RICHARD A PICCOLO
K974064 10/27/1997 MICRO X RESIDUAL TEST STRIPS REPROCESSING PRODUCTS CORP. WALTER JANSEN
K974426 10/27/1997 POTENCY TEST STRIPS, INDICATOR TEST STRIPS REPROCESSING PRODUCTS CORP. WALTER B JANSEN
K974081 10/29/1997 RESOUND STEALTH CIC RESOUND CORP. KRISTA M BUCKLES
K973875 10/10/1997 RINOFLOW MICRONIZED E.N.T. WASH SYSTEM RESPIRONICS, INC. FRANCIS X DOBSCHA
K973920 10/15/1997 STARDUST RESPIRONICS, INC. RAJI S KASBEKAR
K973943 10/16/1997 INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K973892 10/14/1997 RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE) RUSCH INTL. JAMES R WHITNEY
K974021 10/22/1997 SIGNAL PREGNANCY TEST KIT SA SCIENTIFIC, INC. HARBI SHADFAN
K973792 10/06/1997 EASYSAFE RETRACTING NEEDLE SYRINGE SAF-T-MED, INC. JAMES ERBS
K973830 10/07/1997 POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE SAFE GLOVE LTD. ED SING
K973831 10/07/1997 PRE-POWDERED PATIENT EXAMINATION GLOVE SAFE GLOVE LTD. ED SING
K973911 10/14/1997 2 GALLON ALTERNATE CARE SHARPS CONTAINER SAGE PRODUCTS, INC. KAREN PINTO
K973791 10/06/1997 ABC CALIBRATION VERIFIERS SC CALIBRATORS & CONTROLS LLC. STEVE CHIAMORI
K973790 10/06/1997 ABC LINEARITY VERIFIERS SC CALIBRATORS & CONTROLS LLC. ROY F SCHALL JR.
K973751 10/01/1997 MT-200 SCHILLER AMERICA, INC. MARKUS MARITZ
K974039 10/16/1997 SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE SCHWARTZ ELECTRO-OPTICS, INC. TIMOTHY J SHEA
K974122 10/31/1997 ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA SCIENTIFIC HEALTH CARE HENRY WOO
K973749 10/01/1997 FRAG COMMANDER SCIERAN TECHNOLOGIES, INC. ROD ROSS
K973945 10/16/1997 LUGE GUIDE WIRE SCIMED LIFE SYSTEMS, INC. JILL TOWNSEND
K973996 10/21/1997 CLEARLINE PLUS, DENTAL WATERLINE FILTER SCITECH SOLUTIONS, INC. CLIVE DEFTY
K973742 10/01/1997 SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM SENDX MEDICAL, INC. RUBEN CHAIREZ
K973914 10/14/1997 SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR SENSE TECHNOLOGY, INC.
K974121 10/31/1997 LUBRICATED BAGGY TACTYLON CONDOM SENSICON CORP. JEFF D GRANT
K973938 10/15/1997 ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER SFRI, INC. GERALD ODSTRCHEL
K974120 10/31/1997 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI SUPER GLOVES CO., LTD. SUSAN D GOLDSTEIN-FALK
K973802 10/06/1997 SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM SHIMADZU MEDICAL SYSTEMS YASUHARU ISHII
K973799 10/06/1997 CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K973971 10/17/1997 KION ANESTHESIA SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. DAVID SIMARD
K973917 10/15/1997 CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K974013 10/22/1997 EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K973862 10/09/1997 PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS SIMS DELTEC, INC. LISA STONE
K973856 10/09/1997 GIOTTO HT SITCO, INC. ROBERT H MCCARTHY
K973965 10/17/1997 SMART MOTORIZED VIEWER SMARTLIGHT, LTD. DAN BEN-ZEEV
K973747 10/01/1997 CONTROLLED TEMPERATURE CABINET SYSTEM SMITH DURWARD FARIES, JR.
K973748 10/01/1997 TEMPO AND TEMP H20 SMITH DURWARD FARIES, JR.
K973843 10/08/1997 MSI PRESSURE INFUSOR SMITH ASSOC. E.J. Smith
K973854 10/03/1997 ORION ANTERIOR CERVICAL PLATE SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K974017 10/22/1997 TIMESH SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K973880 10/14/1997 SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM SONIX TECHNOLOGIES, INC. JEANNETTE SELOOVER JOHNSON
K973798 10/06/1997 S-357 VIDEO IMAGING SYSTEM SOPRO PIERRE MONTILLOT
K973796 10/06/1997 S-41 &41S VIDEO IMAGING SYSTEM SOPRO PIERRE MONTILLOT
K973795 10/06/1997 S-52 ELECTRONIC VIDEO LAPAROSCOPE SOPRO PIERRE MONTILLOT
K973794 10/06/1997 S-57 VIDEO IMAGING SYSTEM SOPRO PIERRE MONTILLOT
K974020 10/22/1997 SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM SPINAL CONCEPTS, INC. TEENA M AUGOSTINO
K973815 10/07/1997 HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM L AIK
K973801 10/06/1997 HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM L AIK
K973904 10/14/1997 POLYMER LATEX EXAMINATION GLOVES SRI JOHANI SDN. BHD. LIM LEE AIK
K973903 10/14/1997 POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K973805 10/06/1997 IMAGEACCESS SYSTEM STORCOMM, INC. GEORGE M TREIBER
K973837 10/08/1997 CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL SULZER ORTHOPEDICS, INC. SHAVAWN EVANS PARDUHN
K974105 10/31/1997 KERR COMPOMER SYBRON DENTAL SPECIALTIES, INC. WENDY A URTEL
K974068 10/28/1997 PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL TECNOL MEDICAL PRODUCTS, INC. RUTH JONES
K974030 10/23/1997 CARPAL ENGAGING WRIST FUSION PLATE TERRAY CORP. TEAL RENALS
K974025 10/23/1997 ANSPACH SHIELDED ATTACHMENT THE ANSPACH EFFORT, INC. WILLIAM E ANSPACH III
K974036 10/24/1997 PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE THE PROMETHEUS GROUP RICHARD HORTON
K973882 10/14/1997 EL-B2GP1SCR THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K974065 10/27/1997 POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM) TILLOTSON HEALTHCARE CORP. EDWARD MARKOVIC
K974040 10/24/1997 C3 EXTERNAL MALE BLADDER CONTROL DEVICE TIMM RESEARCH CO. DAVID ANDERSON
K973908 10/14/1997 AUKLET CT SCANNER, TSX-003A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K973814 10/07/1997 TRUMP-IT II AND MAGNUM 250 VALLEY WEST, INC. JULIE H BYERLY
K973889 10/14/1997 VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE VARIAN MEDICAL SYSTEMS, INC. CHARLES H WILL
K973960 10/16/1997 MODEL 37-185 VICTOREEN, INC. LINDA S NASH
K974112 10/31/1997 VACUDAP, MODEL 2000, 2001 VICTOREEN, INC. LINDA S NASH
K973975 10/20/1997 RESPIRTECHPRO VORTRAN MEDICAL TECHNOLOGY 1, INC. GORDON A WONG
K973773 10/02/1997 DAPELLE HAIR REMOVER WELLQUEST INTL., INC. STEVEN MISHAN
K974018 10/22/1997 WILSON-COOK 10 SHOT MULTI-BAND LIGATOR WILSON-COOK MEDICAL, INC. PAULA JOYCE
K974118 10/31/1997 WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET WORLDWIDE MEDICAL TECHNOLOGIES, LLC GARY LAMOUREUX
K974159 10/14/1997 OSOM HCG-URINE TEST MODEL 101 WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K973744 10/01/1997 UNICATH SP BI-PLANE (MODEL M269 & M289) XRE CORP. WAYNE V LOOMER


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