FDA 510(k) Decisions During May, 1988  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K881618 05/09/1988 ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 3M COMPANY JACQUELYN A BUSH
K880938 05/13/1988 ITE TYPE HEARING AID ABS MODEL A BETTER SOUND CORP. ROBERT C BARE
K875029 05/27/1988 ABBOTT BREATH ACETONE ANALYZER ABBOTT LABORATORIES E NEVALAINEN
K872881 05/13/1988 ABBOTT CMV-M EIA KIT ABBOTT LABORATORIES JEAN FRYDMAN
K874127 05/06/1988 ABBOTT TESTPACK RSV ABBOTT LABORATORIES JEAN FRYDMAN
K880469 05/23/1988 CHLAMYDIAZYME(TM) ABBOTT LABORATORIES JEAN FRYDMAN
K881345 05/11/1988 IMX FERRITIN ABBOTT LABORATORIES MATT KLAMRZYNSKI
K880821 05/06/1988 RESUBMITTED ABBOTT TESTPACK ROTAVIRUS ABBOTT LABORATORIES JEAN FRYDMAN
K874465 05/25/1988 SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD ABBOTT LABORATORIES FREDERICK GUSTAFSON
K880616 05/02/1988 MINOS AUTOMATIC CELL COUNTER ABX, INC. WILLIAM M DOUGHERTY
K880993 05/11/1988 AMALGAMATOR ACECODENT, INC. JAMES HWANG
K880881 05/04/1988 ARTUS DISPOSABLE SHEATHS/CUTTERS ACUFEX MICROSURGICAL, INC. RICHARD E FRANKO
K874363 05/02/1988 ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI. ACUSON COMPUTED SONOGRAPHY J GALLAGHER
K874861 05/11/1988 ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. ACUSON COMPUTED SONOGRAPHY ROBERT J GALLAGHER
K881688 05/18/1988 DTV-4114 FLUOROSCOPIC TELEVISION CAMERA ADAC LABORATORIES GARY L PEMBROKE
K875158 05/31/1988 ACS FUNNEL INTRODUCER ADVANCED CARDIOVASCULAR SYSTEMS, INC. KEVIN CORRIGAN
K880472 05/16/1988 ADVANCE* AND DAISY* PREGNANCY TEST ADVANCED CARE PRODUCTS JEAN R GRIEVE
K881208 05/16/1988 PROBE SHEATH FOR ADMS ULTRASOUND PROBE ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. J ALLSEBROOK
K880953 05/13/1988 ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG ADVANCED SURGICAL PRODUCTS, INC. TODD J HESSEL
K881669 05/13/1988 MVR/STILETTO BLADE 20GA. - P/N 1900 ADVANCED SURGICAL PRODUCTS, INC. TODD J HESSEL
K880952 05/13/1988 PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS ADVANCED SURGICAL PRODUCTS, INC. TODD J HESSEL
K881927 05/25/1988 PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES ADVANCED SURGICAL PRODUCTS, INC. TODD J HESSEL
K881369 05/13/1988 ADVANCE DIAGNOSTICS DISPOSABLE EYECUP ADVANTAGE DIAGNOSTICS CORP DAN MISENHIMER
K874027 05/27/1988 LIPASE UV [TOYO] ADVOCACY INTERNATIONAL, LTD. RICHARD T NEY
K875068 05/10/1988 AIDS SAFETY BELT AIDS SAFETY BELT, INC. HERMAN THOMAS
K880781 05/11/1988 DATALOGGER CHART RECORDER AIR-SHIELDS, INC. FRANCIS X CASEY
K880989 05/13/1988 ATS CRYPTOSPORIDIUM STAIN SET ALPHA-TEC SYSTEMS, INC. LAURIE A WILLIAMS
K881879 05/13/1988 ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 ALPHA-TEC SYSTEMS, INC. LAURIE A WILLIAMS
K881949 05/25/1988 ATS NAC-PAC SET ALPHA-TEC SYSTEMS, INC. LAURIE A WILLIAMS
K881698 05/13/1988 ATS PVA FIXATIVE SOLUTION ALPHA-TEC SYSTEMS, INC. LAURIE A WILLIAMS
K880917 05/27/1988 LYTENING 5 AMDEV, INC. ARTHUR G SCHNEIDER
K881379 05/16/1988 WESBLOT RNP-SM TEST AMERICAN BIONETICS, INC. FRANK R RUDERMAN
K881704 05/04/1988 EASY TENS AMERICAN IMEX JOAN FONG
K880823 05/31/1988 AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT AMERSHAM CORP. FRANK J LYMAN
K881373 05/27/1988 AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT AMERSHAM CORP. FRANK J LYMAN
K874663 05/31/1988 MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM AMETEK/THERMOX INSTRUMENTS DIVISION RICHARD W WANEK
K880163 05/17/1988 PREGNANCY (HCG) CARD & LIQUID TEST AMPCOR, INC. RAYMOND GOULD
K880746 05/31/1988 STERILE NEEDLE FOR BLOOD COLLECTION APPLIED PLASTICS TECHNOLOGY, INC. ROSEANNE HIRSCH
K880987 05/13/1988 INJECTOR HANDLE WITH SYRINGE APPLIED VASCULAR DEVICES, INC. SAID S HILAL
K874505 05/20/1988 CONTAIN(TM) ARBOR TECHNOLOGIES, INC. DAWN I MOORE
K881652 05/11/1988 AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID AUDIOTONE, INC. JAMES A NUNLEY
K881653 05/13/1988 AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID AUDIOTONE, INC. JAMES A NUNLEY
K881737 05/13/1988 AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID AUDIOTONE, INC. JAMES A NUNLEY
K881738 05/13/1988 AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID AUDIOTONE, INC. JAMES A NUNLEY
K880102 05/26/1988 BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K881052 05/26/1988 CHECK VALVE BAXTER HEALTHCARE CORP. DENNIS OCWIEJA
K881279 05/18/1988 EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET BAXTER HEALTHCARE CORP. JOHN L ELY
K881258 05/27/1988 PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II BAXTER HEALTHCARE CORP. KRISTA U SMALLEY
K881440 05/27/1988 IQ POTASSIUM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC J ARNSBERGER
K880913 05/11/1988 M424 EMG MONITOR BIO-LOGIC DEVICES HOWARD BAILIN
K880916 05/11/1988 M444 EMG MONITOR BIO-LOGIC DEVICES HOWARD BAILIN
K880914 05/11/1988 T824 TEMPERATURE MONITOR BIO-LOGIC DEVICES HOWARD BAILIN
K881655 05/27/1988 SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL BIOMEDICAL RESEARCH & DEVELOPMENT LABORATORIES INC SESHACHALAM DUTTA
K875316 05/11/1988 BIONICA MDS 110 PCA BIONICA, INC. VLADIMIR FEINGOLD
K880447 05/27/1988 MULTI-FUNCTION BLOOD GAS CONTROL BIONOSTICS, INC. BRUCE R WILLIAMS
K871442 05/20/1988 BIOSOUND MMI ULTRASOUND BIOSOUND, INC. ROBERT COURTNEY
K881366 05/16/1988 BIOTROL BUN ENZYMATIQUE UV H.P. BIOTROL, USA, INC. ALLAN C MURPHY
K881267 05/16/1988 BIOTROL CK MONOEACTIF BIOTROL, USA, INC. ALLAN C MURPHY
K881702 05/27/1988 BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. BIOTROL, USA, INC. ALLAN C MURPHY
K881328 05/18/1988 MODEL 375 ECG BIRTCHER CORP. DONALD L EMMONS
K881011 05/13/1988 BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS BIVONA MEDICAL TECHNOLOGIES SHAPIRO, M.D.
K881744 05/03/1988 PORGES URETERAL STENT BIVONA MEDICAL TECHNOLOGIES SHAPIRO, M.D.
K875118 05/16/1988 PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 BLOODFLOW LABORATORY, INC. PINE, MD
K880720 05/20/1988 MONTGOMERY NERVE STIMULATOR BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K881858 05/27/1988 ACE ICPM SIDE PORTED NEEDLE BUCKMAN CO., INC. DAVID W SCHLERF
K881312 05/23/1988 LAMINARIA BUSSE HOSPITAL DISPOSABLES, INC. PARTHA BASUMALLIK
K881460 05/04/1988 SMOKEVAC ELECTORSURGICAL PENCIL BYRON MEDICAL BYRON ECONOMIDY
K880903 05/06/1988 BARD (R) ESKA ERECTIOMETER C.R. BARD, INC. DONNA J WILSON
K880763 05/24/1988 NEZHAT IRRIGATION PUMP SYSTEM CABOT MEDICAL CORP. TODD POLK
K880088 05/04/1988 CADWELL EXCEL CADWELL LABORATORIES, INC. CARLTON M CADWELL
K881183 05/04/1988 VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H CAMINO LABORATORIES, INC. DAN MCKAY
K880615 05/13/1988 AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30 CARDIOTECHNICS, INC. HARROL G JONES
K880308 05/27/1988 CALCIUM CATACHEM, INC. LUIS P LEON
K880306 05/20/1988 EMERGENCY-CLEAN UP(TM) ECP CDC PRODUCTS CORP. JAYNE DROBBIN
K880401 05/31/1988 DENVER PERITONEO-VENOUS SHUNT CODMAN & SHURTLEFF, INC. THOMAS J COURAGE
K880754 05/12/1988 DRI-CLAVE LIQUID KLEENZALL COLUMBUS DENTAL MFG. CO. CHERYL V ZIMMERMAN
K881603 05/04/1988 ULTRA TRACTION COMPONENT EQUIPMENT MFG., INC. TIMOTHY J JUNK
K880930 05/31/1988 MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE COPPER LASERSONICS, INC. CHARLES L ROSE
K880294 05/27/1988 DART PHENYTOIN COULTER ELECTRONICS, INC. A RICHARDSON-JONES
K881510 05/06/1988 CLP ABNORMAL COAGULATION CONTROL CREATIVE LABORATORY PRODUCTS, INC. ROY SPECK
K880712 05/06/1988 CLP NORMAL COAGULATION CONTROL CREATIVE LABORATORY PRODUCTS, INC. ROY SPECK
K874546 05/11/1988 SIM MODULE CRITIKON COMPANY,LLC RAYMOND E URSICK
K881326 05/27/1988 HDL CHOLESTEROL PRECIPITATING PROCEDURE DATA MEDICAL ASSOCIATES, INC. MARJORIE B POTTS
K881484 05/04/1988 BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING DAVIS & GECK, INC. PELLETIER
K881184 05/25/1988 INTERTECH STERILE WATER FOR INHALATION DELMED, INC. RONALD GUIDO
K880542 05/02/1988 DENTALVISION TV SYSTEM DENTSPLY INTL. JOHN O SEMMELMAN
K880774 05/18/1988 SPECTRUM DENTSPLY INTL. JOHN O SEMMELMAN
K880269 05/06/1988 LCS FEMORAL HIP PROSTHESIS DEPUY, INC. BARRY R SISSON
K881088 05/31/1988 ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) DEVICES FOR VASCULAR INTERVENTION, INC. DIANE RUPPERT
K880692 05/27/1988 ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) DIAGNOSTIC CHEMICALS, LTD. (USA) CALLBECK, R.T.
K875361 05/13/1988 SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT DISEASE DETECTION INTERNATIONAL, INC. EL-BADRY
K875366 05/23/1988 THE DDI SERODOT HERPES IGG TEST KIT DISEASE DETECTION INTERNATIONAL, INC. EL-BADRY, PHD
K880860 05/26/1988 CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 DLP, INC. VAN HOF
K881643 05/17/1988 BATTERY PACKS FOR CARDIOVASCULAR UNITS DOWIT SERVICE CO., INC. JOAN POTOSNAK
K881229 05/27/1988 AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 EM DIAGNOSTIC SYSTEMS, INC. RAYMOND L MILLER
K881337 05/27/1988 EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 EM DIAGNOSTIC SYSTEMS, INC. RAYMOND L MILLER
K881521 05/31/1988 MODIFIED SERVO SYRINGE ENGINEERING, INC. KEVIN W SMITH
K874850 05/20/1988 EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER EPI-SCAN CORP. DAVID R LONGMIRE,MD
K880533 05/13/1988 VITEL III CM EQUIMED CORP. DAVID C GUST
K880490 05/03/1988 BLUE PLASTIC EYE SHIELD EYE GARTER COMPANY, INC. GOFFMAN, MD
K880418 05/31/1988 INCOS 50 MASS SPECTROMETER FINNIGAN CORP. LEHRER, PHD
K880780 05/12/1988 HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG FIRST MEDICAL DEVICES CORP. BRUCE HAGGAR
K881785 05/31/1988 N.S. CADEE FIRST SCIENTIFIC, DIV. GERALD HOWARD
K880531 05/02/1988 MAMMOGRAPHIC X-RAY SYSTEM ATHENA FISCHER IMAGING CORP. RICHARD LUCAS
K880519 05/04/1988 SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650 FISCHER IMAGING CORP. RICHARD LUCAS
K880521 05/04/1988 SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650 FISCHER IMAGING CORP. RICHARD LUCAS
K880524 05/04/1988 THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100 FISCHER IMAGING CORP. RICHARD LUCAS
K880523 05/04/1988 THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75 FISCHER IMAGING CORP. RICHARD LUCAS
K880522 05/04/1988 THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80 FISCHER IMAGING CORP. RICHARD LUCAS
K881275 05/16/1988 URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II FISHER SCIENTIFIC CO., LLC. B BREUER,PHD
K875381 05/03/1988 ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER FORD LABORATORIES, INC. FRANKLIN C FORD
K880644 05/06/1988 ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) FRED SAMMONS, INC. SUSAN BLEDSOE
K880485 05/02/1988 XENEX DENTAL ROULETTE G & A INDUSTRIES, INC. GIL SHAPIRA
K880849 05/11/1988 EXAMIX DISPENSER G-C INTL. CORP. DONALD A MCKENZIE
K880848 05/16/1988 FUJI CAP II CAPSULE & APPLIER G-C INTL. CORP. DONALD A MCKENZIE
K882012 05/23/1988 LIFESTYLE SOF. CARE GEL CHAIR CUSHION GAYMAR INDUSTRIES, INC. PETER POWELL
K880829 05/27/1988 GDS ENZYMATIC ACETAMINOPHEN REAGENT GDS TECHNOLOGY, LLC. DE CASTRO
K881882 05/25/1988 SENOGRAPHE 600T AND 600TS SENIX HF GENERAL ELECTRIC CO. KROGER, PHD
K882019 05/31/1988 SMS 90-15 R&F TABLE AND SMS 14" SPOT FILM DEVICE GENERAL ELECTRIC CO. KROGER, PHD
K880506 05/20/1988 MODIFIED EVA-MIX AND DI-MIX BAGS GIL-MED INDUSTRIES C/O KEGAN & KEGAN, LTD. ESTER O KEGAN
K874839 05/13/1988 STAT-SAT GISH BIOMEDICAL, INC. JEANNE PIERSON
K873012 05/02/1988 INFANT CANNULA GRESCO INTERNATIONAL, INC. GEORGE E SINKO
K875159 05/06/1988 DETECTADOT SYSTEM 2000 CMV IGG TEST GULL LABORATORIES, INC. FRED W RACHFORD
K874377 05/20/1988 ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY HARRINGTON ARTHRITIS RESEARCH CENTER JAMES B KOENEMAN
K881730 05/13/1988 BREAST LOCALIZATION NEEDLES HART ENTERPRISES, INC. ALAN TAYLOR
K881003 05/18/1988 DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 HEALTHCHECK CORP. BALZER, JR.
K881590 05/23/1988 ADFUSE(TM) HEALTHTEK, INC. JOHN T WRIGHT
K880698 05/06/1988 TITAN GEL-PC GLYCO-HEME(TM) SYSTEM HELENA LABORATORIES PAT FRANK
K881262 05/06/1988 CARAWAY TUBES, HEPARIN AND PLAIN HELPS PRODUCTS, INC. BRIAN LEMAY
K881186 05/13/1988 MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL HELPS PRODUCTS, INC. BRIAN LEMAY
K881187 05/06/1988 NATELSON TUBES, HEPARIN AND PLAIN HELPS PRODUCTS, INC. BRIAN LEMAY
K880699 05/02/1988 ENDOMED CV405 HENLEY INTL. ERNEST J HENLEY,PHD
K881136 05/18/1988 HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI. HEWLETT-PACKARD CO. NICHOLAS POLY
K880908 05/03/1988 MODEL PC ARGON LASER HGM, INC. BILL PAPWORTH
K875170 05/23/1988 EBNA ANTIBODY HILLCREST BIOLOGICALS MOORE, PHD
K881005 05/27/1988 IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG ICN BIOMEDICALS, INC. BURNS, PHD
K881308 05/17/1988 BREATH-EASY ICOR AB CARL HAMILTON
K881201 05/16/1988 HR VACUTRAC ICU MEDICAL, INC. FRED MCLENDON
K881666 05/06/1988 HR(TM) INTRAVASCULAR CATHETER ICU MEDICAL, INC. FRED MCLENDON
K880231 05/25/1988 MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER IDEAS FOR MEDICINE, INC. LORNA K LINVILLE
K881276 05/04/1988 HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS IME CO. LTD. KEVIN G MCANANEY
K881257 05/27/1988 EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT IMMUNOTECH CORP. FRANCIS E CAPITANIO
K874590 05/11/1988 INNOVATIVE IMPLANTS AND COVER SCREWS IMPLANT INNOVATIONS INTERNATIONAL, INC. RICHARD J LAZZARA
K874738 05/02/1988 10 AND 12 FRENCH VESSEL DILATORS IMPRA, INC. JAMES M MCHANEY
K880168 05/11/1988 INCSTAR'S BIRCH ALLERGEN DISC INCSTAR CORP. JOHN G YAGER
K880221 05/11/1988 INCSTAR'S PIGWEED ALLERGEN DISC INCSTAR CORP. JOHN G YAGER
K874540 05/11/1988 MARSH ELDER ALLERGEN DISC INCSTAR CORP. JOHN G YAGER
K874883 05/11/1988 WALNUT ALLERGEN DISC INCSTAR CORP. JOHN G YAGER
K881501 05/18/1988 MODIFIED IDS RAPID NH SYSTEM INNOVATIVE DIAGNOSTIC SYSTEMS, INC. LOUIS A ERIQUEZ,PHD
K875178 05/25/1988 MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD INTERMEDICS, INC. LISA S JONES
K875100 05/24/1988 MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD INTERMEDICS, INC. LISA S JONES
K881193 05/18/1988 ACCUTONE "IN-THE-EAR" HEARING AID INTERSTATE HEARING AID SERVICE JAMES CULP
K881508 05/25/1988 OCHSNER & MICRON FABRIC PATCH INTERVASCULAR, INC. MICHAEL P DAYTON
K880831 05/10/1988 LARGE LUMEN "Y" ADAPTER W/ROTATING DEVICE INTERVENTIONAL MEDICAL, INC. DENIS T KOKERNAK
K880865 05/02/1988 RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 INVACARE CORP. JAMES R THALER
K881951 05/19/1988 RIDE-LITE 9000 SERIES WHEELCHAIR INVACARE CORP. JAMES R THALER
K881762 05/04/1988 ROLLS 2000 SERIES WHEELCHAIR INVACARE CORP. JAMES R THALER
K880348 05/11/1988 PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI. J.F. JELENKO & CO., INC. MARCY KRAMER
K880871 05/20/1988 GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER JOHN WAGNER ASSOCIATES, INC. ERICH BUSSIAN
K880956 05/11/1988 SNOAR(TM) OPEN AIRWAY APPLIANCE KENT J. TOONE, D.D.S. KENT J TOONE,D.D.S.
K880684 05/11/1988 "XR PRIMER" KERR CORPORATION (DANBURY) KURZMAN, PC
K880685 05/11/1988 PORCELITE DUAL CURE CEMENT KERR CORPORATION (DANBURY) KURZMAN, PC
K881004 05/12/1988 OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR KEYMED, INC. ROGER GRAY
K880850 05/26/1988 KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE KMB MEDICAL PRODUCTS CO. C. W KEITH
K875036 05/18/1988 INTRA-AORTIC BALLOON PUMP MODEL KAAT KONTRON INSTRUMENTS, INC. DAVID CROMWICK
K881219 05/03/1988 AUTOMATIC PERIMETER, AP-340 KOWA OPTIMED, INC. MIKE YAMASHITA
K881443 05/27/1988 LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY LONDON DIAGNOSTICS, INC. CHIP WHITACRE
K881910 05/18/1988 LABELING CHANGE TO SURGICAL FACE MASK LOUIS M. GERSON CO., INC. WILLIE YUNG
K880584 05/31/1988 URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C MACH DIAG. C/O WICHITA STATE UNIVERSITY JAMES A JACKSON
K875181 05/27/1988 MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM MARION LABORATORIES, INC. GUINTY, JR
K881419 05/25/1988 PLASTIC FRAME & LENS SUNGLASS MARKETING INNOVATIONS INTL., INC. JAMES SMITH
K874606 05/06/1988 CATHRA GRAM POSITIVE SCREEN MCT MEDICAL, INC. ANN WEAVER
K881283 05/26/1988 MEADOX INTRA-AORTIC GRAFT MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MADELEINE KENDEFFY
K881027 05/26/1988 MSI 2002 SERIES BED MED SERVICE, INC. BRUCE BAGGETT
K881965 05/31/1988 MSI 5000 SERIES BED MED SERVICE, INC. BRUCE BAGGETT
K880877 05/31/1988 CONTRAST INJECTION DEVICE MED-WEST, INC. DAVID C BEATTIE
K880196 05/06/1988 LAMINARIA MEDGYN PRODUCTS, INC. LAKSHMAN AGADI
K881300 05/17/1988 MAGNESIUM LIQUID STABLE REAGENT SET MEDICAL ANALYSIS SYSTEMS, INC. DONNA L ANDERSON
K880152 05/31/1988 PAR(TM) BRAND DRUG OF ABUSE CONTROLS MEDICAL ANALYSIS SYSTEMS, INC. DONNA L ANDERSON
K880802 05/26/1988 SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 MEDICAL ENGINEERING CORP. MARILYN WAXBERG
K880801 05/26/1988 SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 MEDICAL ENGINEERING CORP. MARILYN WAXBERG
K881313 05/19/1988 IQK-200 MEDICAL REPACKERS CO. BILLY A HODGES
K881392 05/31/1988 CARDICAD(TM) MEDICAL/SURGICAL SPECIALTIES, LTD. JAMES L PHILLIPS
K881770 05/31/1988 EPICARDIA LE/FD MEDICOMP, INC. JOE RIFFE
K881596 05/27/1988 FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 MEDIX BIOTECH, INC. HUANG, PHD
K880991 05/25/1988 LASER OPTICAL CATHETER SYSTEM MEDLINE INDUSTRIES, INC. JO BREHM
K880776 05/02/1988 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM MEDSURG INDUSTRIES, INC. TOM BONNER
K880777 05/24/1988 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM MEDSURG INDUSTRIES, INC. TOM BONNER
K880779 05/09/1988 MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY MEDSURG INDUSTRIES, INC. TOM BONNER
K880771 05/03/1988 MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM MEDSURG INDUSTRIES, INC. TOM BONNER
K880693 05/11/1988 MEDSURG MYELOGRAM TRAY MEDSURG INDUSTRIES, INC. THOMAS BONNER
K880671 05/06/1988 MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER MEDTRONIC BLOOD SYSTEMS, INC. SHARON D ROCKWELL
K881712 05/25/1988 MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT MEDTRONIC VASCULAR JENNIFER M MARRONE
K881491 05/25/1988 MODEL 3487A PISCES EPIDURAL LEAD MEDTRONIC VASCULAR DAVID H MUELLER
K880595 05/06/1988 HORIZON 2000/S 266-XXX-XXX MENNEN MEDICAL, INC. RONALD A WIDMAN
K875167 05/31/1988 HORIZON 9000 MENNEN MEDICAL, INC. LEWIS, PHD
K881001 05/13/1988 MENTOR WET-FIELD*II COAGULATOR MENTOR O & O, INC. MARK TOMA
K875138 05/13/1988 TRICHOMATE(R) SUPER MERCIA DIAGNOSTICS LTD. LOUISE OLLIVER
K880574 05/04/1988 MODIFIED IMIPENEM SUSCEPTIBILITY POWDER MERCK, SHARP & DOHME BLOIS, PHD
K880943 05/26/1988 MICROLINE CAT #100 MICROLINE PENTAX, INC. DE LAFORCADE
K880605 05/26/1988 LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER MILES LABORATORIES, INC. STERNBERG, PHD
K873565 05/13/1988 SNAP(R) ROTAVIRUS DIAGNOSTIC KIT MOLECULAR BIOSYSTEMS, INC. PETER J WESTKAEMPER
K881803 05/31/1988 UVMAX KINETIC MICROPLATE READER MOLECULAR DEVICES CORP. SHEILA W PICKERING
K880347 05/03/1988 ANESTHESIA/RETROBULBAR NEEDLES MYOCURE, INC. JENSEN, MD
K880346 05/03/1988 CANNULAS MYOCURE, INC. JENSEN, MD
K880345 05/03/1988 CYSTOTOMES/KNIFES MYOCURE, INC. JENSEN, MD
K881957 05/20/1988 HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT N-S MEDICAL PRODUCTS KEITH L STAHL
K881956 05/20/1988 NATIONAL-STANDARD NEEDLE HOLDER N-S MEDICAL PRODUCTS KEITH L STAHL
K881356 05/19/1988 EXTERNAL PACEMAKER WIRE DRESSING CHANGE NEAL & ASSOC., INC. CAROL NEAL
K880487 05/06/1988 NEOTECH MECONIUM ASPIRATOR (STERILE) NEOTECH PRODUCTS, INC. THOMAS R THORNBURY
K875205 05/31/1988 TRI-FLOW CATHETER NEURODYNAMICS, INC. MARGARET MEADE
K880929 05/25/1988 NIDEK CV-4000 NIDEK, INC. CARL R JORDAN
K881278 05/25/1988 SPECTACLE, FRAME AND SUNGLASSES NOUVELLE LIGNE PARIS STAN WENTZ
K881255 05/16/1988 NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K881418 05/31/1988 CRANIOTOME BLADE OR NEURO BLADE NUELL AIR EQUIPMENT & HOSPITAL SUPPLIES, INC. DARLENE HOLSCLAW
K880601 05/06/1988 WIRE PASS DRILL BITS NUELL AIR EQUIPMENT & HOSPITAL SUPPLIES, INC. DARLENE HOLSCLAW
K880572 05/10/1988 OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR OHMEDA MEDICAL DEANA D DICKERSON
K880661 05/02/1988 FIBEROPTIC CATHETER OPTIMED TECHNOLOGIES, INC. RONALD J EHMSEN,SCD
K881281 05/18/1988 COAG-A-MATE(R) XM ORGANON TEKNIKA CORP. TONI M STIFANO
K881435 05/27/1988 PREGNOSPIA II ORGANON TEKNIKA CORP. SHELDON MAZURSKY
K881348 05/02/1988 VERIFY(R) REFERENCE PLASMA ORGANON TEKNIKA CORP. TONI M STIFANO
K872541 05/13/1988 ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. ORTHO DIAGNOSTIC SYSTEMS, INC. PATRICIA BONNESS
K874917 05/10/1988 PYTHON AMBULATORY BLOOD PRESSURE MONITORING SYSTEM OXFORD MEDILOG, INC. MICHAEL J SMITH
K881824 05/24/1988 LASER MICROMANIPULATOR PFIZER LASER SYSTEMS COZEAN, PHD
K880890 05/11/1988 THE S.A.F.E. SYSTEM PFIZER LASER SYSTEMS LINDA DIBENEDETTO
K881493 05/20/1988 PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. PHARMACIA DELTEC, INC. W NUMAINVILLE
K881690 05/20/1988 PORT-A-CATH PORTAL INTRODUCER FORCEPS PHARMACIA DELTEC, INC. EDWARD NUMAINVILLE
K880899 05/16/1988 PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA PHARMACIA, INC. ALBERT P MAYO
K875251 05/11/1988 ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. W. J GERBER
K874558 05/02/1988 SL SERIES, SL 15, 18, 20 & 25 PHILIPS MEDICAL SYSTEMS, INC. WILLIAM MCMAHON
K880554 05/06/1988 VSM(R) R2 PAPER CHART RECORDER PHYSIO-CONTROL CORP. SHERRI L POCOCK
K881496 05/31/1988 LINDER NASOTRACHEAL AIRWAY POLAMEDCO, INC. LINDER, MD
K880498 05/13/1988 RM-301 PATIENT MONITOR PPG INDUSTRIES, INC. STEVE BRODY
K882090 05/26/1988 HIP SAVER PRIDE HEALTH CARE, INC. THOMAS KRETCHIK
K882091 05/26/1988 STAIR VEYOR PRIDE HEALTH CARE, INC. TOM KRETCHIK
K880442 05/16/1988 BRUSHRITE PRO CARE LABORATORIES, INC. EUGENE M MUELLER
K880589 05/11/1988 ROTA-DENT TOOTH CLEANER PRO-DENTEC THOMAS J MULDOON
K873151 05/31/1988 MODEL 7200A, PRESSURE VENTILATION OPTION PURITAN BENNETT CORP. STEVEN J OJALA
K881634 05/17/1988 SIMPLICITY SERIES 5 QUARTET TECHNOLOGY, INC. STEVE MINER
K881595 05/27/1988 QUIDEL PREGNANCY TEST QUIDEL CORP. ROBIN WEINER
K881161 05/02/1988 TECH-CAL(TM)/MULTIPLE R & D SYSTEMS, INC. KAREN VISKOCHIL
K880880 05/27/1988 RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC REAGENTS APPLICATIONS, INC. ALFRED E PEACOCK,JR
K881143 05/18/1988 IMPULSE TVC (RICHARDS, OMNI, MARCON) RICHARDS MEDICAL CO., INC. ROBERT F GAMES
K881766 05/17/1988 REM 250 THREE WHEELED ELECTRIC CART ROYAL ENTERPRISES MANUFACTURING, INC. PAUL R GRAVES
K875030 05/03/1988 OCU-1 RUDOLPH BEAVER, INC. ROBERT P ZOLETTI
K874482 05/13/1988 REVISED IMMUDIA HEM-SP SCHIFF & CO. KAFADER II
K881197 05/16/1988 SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER SCHNEIDER-SHILLEY (USA) ANN H MORRISSEY
K881598 05/04/1988 SDL TRICHROME STAIN SCIENTIFIC DEVICE LABORATORY, INC. LIPTON, PHD
K881214 05/27/1988 IMMPULSE T, ASSAY REAGENTS SCLAVO, INC. MICHAEL BRINKLEY
K880641 05/13/1988 SENSITITRE STABILITY PLATES SENSITITRE LTD. FRANCES M GRIGGS
K880672 05/06/1988 SENTINEL PULSE OXIMETER SENTINEL MONITORING TECHNOLOGIES, LTD. JERRY W JARRARD
K881343 05/04/1988 DURADERM BUTTERFLY SENTRY MEDICAL PRODUCTS, INC. DAVID SHERATON
K880715 05/09/1988 (MB-650) BLOOD PRESSURE MONITOR SHARP ELECTRONICS CORP. E SABELLA
K881848 05/11/1988 MODIFIED MODEL 2100 ND:YAG LASER SHARPLAN LASERS, INC. STEPHEN DALTON
K881887 05/13/1988 SHARPLAN 719Y MICROSLAD(TM) SHARPLAN LASERS, INC. DALTON
K881870 05/24/1988 SHARPLAN ND:YAG SURGICAL HAND APPLICATORS SHARPLAN LASERS, INC. L. S DALTON
K881873 05/18/1988 INTRODUCTION/DRAINAGE CATHETER & ACCESS SHERIDAN CATHETER CORP. STEEN, PHD
K881745 05/11/1988 INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER SHILEY INFUSAID, INC. NANCY C HALL
K881421 05/04/1988 DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK SHILEY, INC. GANZ POBUDA
K880663 05/11/1988 SHILEY BCD PLUS HEAT EXCHANGER SHILEY, INC. GANZ POBUDA
K881072 05/31/1988 SHILEY FEMORAL ARTERIAL CANNULA SHILEY, INC. RADINE POBUDA
K881074 05/31/1988 SHILEY FEMORAL VENOUS CANNULA SHILEY, INC. RADINE POBUDA
K881006 05/24/1988 STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 SHILEY, INC. GANZ POBUDA
K875370 05/18/1988 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX SHIMADZU PRECISION INSTRUMENTS, INC. HIROYUKI HATTORI
K880499 05/23/1988 HEMOCCULT SENSITIVE TEST SMITH KLINE DIAGNOSTICS, INC. RONALD SCHOENGOLD
K880876 05/20/1988 C-STAT/1000 SONNE MEDICAL, INC. MD
K875337 05/25/1988 HEPARIN COATED LUMINAL PACING CATHETER SPECTRAMED, INC. ROBERT L LEAVITT
K880144 05/23/1988 STANBIO SYPHILIS RPR TEST, NO. 1170 STANBIO LABORATORY WILLIAM CAMPBELL,PHD
K880545 05/31/1988 STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II STIMWEAR PHILIP MUCCIO, CPO
K874921 05/13/1988 HEADFIRST (CONDOM) STUAL PRODUCTS, INC. JAMES SCHISGALL
K881327 05/25/1988 STUART CANNULATED CANCELLOUS BONE FIXATION SCREW STUART DRUG & SURGICAL SUPPLY, INC. ABRAHAM GLASSER
K880724 05/27/1988 LIQUID CHROMATO. COLUMNS SUPELCO, INC. LLOYD A WITTING,PHD
K874569 05/03/1988 SUREDROP EYEDROP GUIDE SUREDROP, INC. WILLIAM SMITH
K881922 05/25/1988 CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE SURGIPATH MEDICAL INDUSTRIES, INC. JOY F MONEK
K880300 05/12/1988 CARDIOBEEPER(R) III SURVIVAL TECHNOLOGY, INC. GARY W LEYLAND
K881357 05/27/1988 EMIT CONVENIENCE PACK: THYROXINE ASSAY SYVA CO. ROGERS, JR.
K880887 05/24/1988 NEOCATH TARIS CORP. WILLIAM J SCHRODER
K881626 05/27/1988 GAMMA-GLUTAMYL TRANSFERASE TECH-CO, INC. CHEN, PHD
K881239 05/31/1988 GAMMA GLUTAMYL TRANSFERASE REAGENT SET TECH-NEAL SCIENTIFIC, INC. ARUN SANGHAVI
K881241 05/27/1988 TOTAL BILIRUBIN REAGENT TECH-NEAL SCIENTIFIC, INC. ARUN SANGHAVI
K881711 05/26/1988 VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. TELECTRONICS AND CORDIS PACING SYSTEMS DUANE A SCHULTZ
K874664 05/31/1988 IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 TELECTRONICS, INC. WILLIAM C NEALON
K881236 05/11/1988 TORAY ANTHRON P-U CATHETERS TORAY INDUSTRIES (AMERICA), INC. KOHKI UENO
K881909 05/26/1988 TOSHIBA DIGITAL CLINICAL THERMOMETER TOSHIBA GLASS CO., LTD. MASAAKI HOSHINO
K880898 05/06/1988 MULTICOR AND PACEMAKERS TPL-CORDIS, INC. W. C NEALON
K881594 05/25/1988 SUNGLASSES TRANSFERS INTL., INC. MIKE FOX
K881211 05/11/1988 TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 TRU-TRAC THERAPY PRODUCTS, INC. DONNA L HAUSLER
K881046 05/13/1988 SUPER PIK MASSAGING PICK FOR ORAL HYGIENE U.S. DENTEK CORP. JAY H GELLER
K881338 05/16/1988 CONDOM-MATE VAGINAL LUBRICANT UPSHER-SMITH LABORATORIES, INC. HARVEY M ARBIT
K880927 05/16/1988 VASCU-CARE ANGIOSCOPE VASCU-CARE, INC. WAYNE LIPSON
K880705 05/31/1988 THERAPEUTIC DRUG STANDARD VERICHEM LABORATORIES, INC. ANTHONY J DIMONTE
K881515 05/23/1988 TEAR VOLUME TESTS VISIONEX, INC. JESSICA AYRES
K874591 05/03/1988 ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY VITREO DYNAMICS, CO. JEFF FREEMAN
K880167 05/18/1988 GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC BARBARA BOYCE-NESBIT
K881732 05/18/1988 GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC BARBARA BOYCE-NESBIT
K881592 05/13/1988 WESCOR MODEL 7300 AEROSPRAY GRAM STAINER WESCOR, INC. WAYNE K BARLOW
K863395 05/24/1988 WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER WESCOR, INC. WAYNE K BARLOW
K881180 05/13/1988 FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG WHITTAKER BIOPRODUCTS, INC. MARIE P REEVES
K880996 05/13/1988 FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG WHITTAKER BIOPRODUCTS, INC. MARIE P REEVES
K874396 05/18/1988 OCO PREPARATIONS WILLIAMS IMPORTING COMPANY, INC. PETER HOPKIN
K881310 05/20/1988 DENT SLEEVE MANOMETRIC CATHETER WILSON-COOK MEDICAL, INC. ROBERT M KELLY
K875332 05/20/1988 IVAC VOLUMETRIC PUMP - MODEL 590 Y KIMBERLY M CARLSON
K881265 05/31/1988 RANEY CLIPS ZIMMER, INC. MAX SHERMAN


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