FDA 510(k) Decisions During April, 1979  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K790654 04/26/1979 CLOSED WOUND VACUUM DRAINAGE SYSTEM 3M COMPANY
K790479 04/03/1979 A-GENT IMMUNOGLOBULINE TEST SYSTEM ABBOTT LABORATORIES
K790329 04/04/1979 A-GENT-HDL REAGENT ABBOTT LABORATORIES
K790297 04/26/1979 DETECTION SYSTEM, MS-2 ELECTROCHEMICAL ABBOTT LABORATORIES
K782013 04/23/1979 GONO-CELL ABBOTT LABORATORIES
K790437 04/03/1979 TRACH CARE KIT ABCO DEALERS, INC.
K790161 04/20/1979 OXYGEN MASK W/RESERVOIR BAG AIRLIFE, INC.
K790162 04/20/1979 OXYGEN MASK, CONCENTRATION AEROSOL MASK AIRLIFE, INC.
K790156 04/20/1979 TRACH T W/DRAINAGE BAG AIRLIFE, INC.
K790266 04/04/1979 SPECTACLE FRAMES ALVA-TECH, INC.
K790338 04/04/1979 COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER AMERICAN OPTICAL CORP.
K790617 04/23/1979 CARBOHYDRATE FERMENTATION MEDIA ANAEROBE SYSTEMS
K790622 04/23/1979 CHOPPED MEAT AGAR ANAEROBE SYSTEMS
K790621 04/23/1979 CHOPPED MEAT GLUCOSE MEDIUM ANAEROBE SYSTEMS
K790616 04/23/1979 ENRICHED THIOGLYCOLLATE MEDIUM ANAEROBE SYSTEMS
K790620 04/23/1979 LOMBARD DOWELL BROTH MEDIUMW/TH REONINE ANAEROBE SYSTEMS
K790619 04/23/1979 LOMBARD-DOWELL BROTH MEDIUM ANAEROBE SYSTEMS
K790624 04/23/1979 LOMBARD-DOWELL BROTH MEDIUM W/LACTATE ANAEROBE SYSTEMS
K790626 04/23/1979 LOMBARD-DOWELL GLUCOSE AGAR ANAEROBE SYSTEMS
K790623 04/23/1979 LOMBARD-DOWELL MILK AGAR ANAEROBE SYSTEMS
K790628 04/23/1979 LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR ANAEROBE SYSTEMS
K790618 04/23/1979 LOMBARD-DOWELL STARCH AGAR ANAEROBE SYSTEMS
K790634 04/10/1979 IMPERVIOUS STERILE STOCKINETTE ANAGO, INC.
K790613 04/23/1979 CHOPPED MEAT GLOCOSE STARCH MEDIUM ANEROBE SYSTEMS
K790615 04/23/1979 CHOPPED MEAT MEDIUM ANEROBE SYSTEMS
K790614 04/23/1979 LOMBARD-DOWELL MEDIUM WITH GLUCOSE ANEROBE SYSTEMS
K781651 04/03/1979 HEALTH POINT ANRITSU AMERICA CO.
K790353 04/20/1979 ACUTE RENAL DIALYSIS TRAY ARGON MEDICAL CORP.
K790366 04/04/1979 URINE CULTURE KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K790635 04/18/1979 Q220F CARDITOMY RESERVOIR/MODIFIED BENTLEY LABORATORIES, INC.
K790645 04/23/1979 ENDOTOME BERKELEY BIO-ENGINEERING
K790369 04/23/1979 EMB/MUELLER-HINTON AGAR BIOMEDIA, INC.
K790469 04/04/1979 STREP BLOOD AGAR-5% SHEEP BLOOD BIOMEDIA, INC.
K790415 04/04/1979 HCP-7 BIOSCIENTIFIC
K790387 04/04/1979 FEEDING TUBE W/ LUBRICANT COATING BIOSEARCH MEDICAL PRODUCTS, INC.
K790248 04/04/1979 NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) BOEHRINGER LABORATORIES
K790199 04/13/1979 VENTILATOR MODEL BV-300 INFANT BOURNS MEDICAL SYSTEMS, INC.
K790280 04/23/1979 AUTOANTIBODY REAGENTS, AFT SYSTEM II CALBIOCHEM-BEHRING CORP.
K790362 04/23/1979 I BRADYKININ & ANTI-BRADYKININ ANTISERUM CAMBRIDGE NUCLEAR CORP.
K790784 04/27/1979 MODEL M25R, OXYGEN ANALYZER CATALYST RESEARCH CORP.
K790785 04/27/1979 MODEL M25RL, (CRC) OXYGEN ANALYZER CATALYST RESEARCH CORP.
K790644 04/26/1979 "SUBMAX" CHASE MFG. CO.
K790293 04/12/1979 CIMARRON 1000 OR 1000-2 CIMARRON INSTRUMENTS, INC.
K790344 04/17/1979 BIPOLAR PERNENOUS VENTRICULAR LEAD CORDIS CORP.
K790212 04/12/1979 CORDIA T CORDIS CORP.
K790579 04/04/1979 MEDISTOR II CYBERMEDIC, INC.
K790571 04/23/1979 QUIK-STAIN DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790250 04/04/1979 LIQUISOL CORTISOL RIA TEST KIT DAMON CORP.
K790515 04/03/1979 BEHIND-THE-EAR HEARING AID DANAVOX, INC.
K790539 04/10/1979 HEARING AID DANAVOX 775V DANAVOX, INC.
K790457 04/04/1979 HEMOGLOBIN CONTROLS DATA MEDICAL ASSOCIATES, INC.
K790283 04/06/1979 PILLOW, CARTER ARM ELEVATION DEPUY, INC.
K790414 04/10/1979 DEVELOPMENT NO. 647 DERINGER-NEY INC.
K790290 04/10/1979 NEY EQUI-HINGE DERINGER-NEY INC.
K790538 04/04/1979 SPONGE COUNTER DEVON INDUSTRIES, INC.
K790416 04/10/1979 DIATEK 500 DIATEK, INC.
K790564 04/12/1979 ADAPTER-STRAIGHT DLP, INC.
K790563 04/12/1979 ADAPTERS-Y-TYPE DLP, INC.
K790502 04/05/1979 DYONICS STEROTOXIC POSITIONER DYONICS, INC.
K790268 04/04/1979 CORTISOL RIA KIT E. R. SQUIBB & SONS, INC.
K790417 04/20/1979 T3 UPTAKE KIT E. R. SQUIBB & SONS, INC.
K790477 04/26/1979 TY RIA KIT, AUTOMATED ASSAY SYSTEM E. R. SQUIBB & SONS, INC.
K790376 04/04/1979 DUPONT ACA CKMB VERIFIERS E.I. DUPONT DE NEMOURS & CO., INC.
K790491 04/04/1979 ITIMIZED INSTRUMENTS E.M. ADAMS
K790629 04/23/1979 KODAK GRAY TONE IMAGING FILM EASTMAN KODAK COMPANY
K790386 04/03/1979 LEAD MODELS MUM 1260, MUM 1290 ELA MEDICAL, INC.
K790309 04/04/1979 CPK ISOENZYME SUBSTRATE ELECTROPHORESIS CORP.
K790744 04/27/1979 LUNG FUNCTION AMPLIFIER EXERCISER EMPIRE PLASTICS MANUFACTURER
K790832 04/30/1979 KETAC APPLIC-CAPSULES ESPE GMBH (US)
K790833 04/30/1979 VISIO-BOND ESPE GMBH (US)
K790554 04/10/1979 EXETER LIP SEAL EXETER MEDICAL LABS, INC.
K790381 04/20/1979 ARTERIOVENOUS SETS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K790305 04/03/1979 ELECTRODES, FERRIS ECG, TYPES 905,906 FERRIS MFG. CORP.
K790525 04/03/1979 HEMATROL S HEMATOLOGY CONTROLS FISHER SCIENTIFIC CO., LLC.
K790498 04/03/1979 LISS REAGENT FISHER SCIENTIFIC CO., LLC.
K790422 04/20/1979 MULTISKAN (78-503-00) FLOW LABORATORIES, INC.
K790692 04/23/1979 TELEVIX GENERAL ELECTRICAL ESPANOLA, S.A.
K790448 04/11/1979 EASYFIL GENERAL REFINERIES, INC.
K781493 04/17/1979 EEG GEL GRAPHIC CONTROLS CORP.
K790609 04/10/1979 AUDIOMETER GRASON-STADLER, INC.
K790583 04/23/1979 QUIK COLUMN METHODOLOGY HELENA LABORATORIES
K790454 04/03/1979 MODEL 78801A PATIENT MONITORS HEWLETT-PACKARD CO.
K781971 04/04/1979 KNEE SYSTEM, QUADRAXIAL CONSTRAINED HEXCEL MEDICAL
K790357 04/04/1979 CPK-CS HOFFMANN-LA ROCHE, INC.
K790501 04/10/1979 PEDIATRIC OSTEOTOMY SYSTEM HOWMEDICA CORP.
K790675 04/18/1979 5300 PERCUSSOR HUDSON OXYGEN THERAPY SALES CO.
K790659 04/30/1979 INFANT SCALE DISPOSABLE LINER HYDRO-MED PRODUCTS, INC.
K790572 04/10/1979 LOUNGE, TILT-A-BODY STRETCH INNOVATIVE PRODUCTS, INC.
K790577 04/23/1979 HEMORRHOIDAL LIGATOR J. SKLAR MFG. CO., INC.
K790471 04/30/1979 JELCO* DISC FILTER-0.2 MICRON JELCO LABORATORIES
K790341 04/04/1979 DELTA-NET JOHNSON & JOHNSON PROFESSIONALS, INC.
K790340 04/12/1979 DELTA-ROL JOHNSON & JOHNSON PROFESSIONALS, INC.
K790298 04/04/1979 RADIOASSAY, CONTROL SERUM I, II, III KALLESTAD LABORATORIES, INC.
K790704 04/12/1979 ANTISERUM TO HUMAN IGG KENT LABORATORIES, INC.
K790705 04/12/1979 ANTISERUM TO HUMAN IGM KENT LABORATORIES, INC.
K790703 04/12/1979 ANTISERUM, HUMAN, IGA KENT LABORATORIES, INC.
K790384 04/10/1979 KIMLON BEDGARD UNDERPAD KIMBERLY-CLARK CORP.
K790664 04/23/1979 MODEL 1309 AUDIO MONITOR LIFE-TECH INSTRUMENTS, INC.
K790663 04/24/1979 MODEL 1750 STANDING URINAL LIFE-TECH INSTRUMENTS, INC.
K790371 04/04/1979 MACOMB LIPID CONTROL MACOMB CHEMICAL CO.
K790531 04/26/1979 ANUS STIMULATOR MADDAK, INC.
K790587 04/03/1979 CANVAS WEDGE MADDAK, INC.
K790558 04/03/1979 CERSA-CANE MADDAK, INC.
K790557 04/03/1979 CRUTCH MADDAK, INC.
K790561 04/03/1979 OFFSET ALUMINUM CANE MADDAK, INC.
K790530 04/03/1979 PUSH BALL INCLINE MADDAK, INC.
K790560 04/10/1979 ROLLCHAIR, ORTHO BUCKET SEAT MADDAK, INC.
K790528 04/03/1979 THERAPY GYROSCOPE MADDAK, INC.
K790529 04/03/1979 WALKING AID MADDAK, INC.
K790040 04/17/1979 P.A.P. TEST KIT, RIA-ZYME MALLINCKRODT CRITICAL CARE
K790763 04/23/1979 MAXI-VAC TM MED GENERAL
K790408 04/30/1979 T-CONNECTOR MEDEX, INC.
K790430 04/23/1979 MEDICA II-F-ASMA TEST KIT MEDICA CORP.
K790245 04/04/1979 STANDARD PECTORALIS MUSCLE IMPLANT MEDICAL ENGINEERING CORP.
K790691 04/16/1979 25-50 EKG RULER MEDICAL ENGINEERING DESIGNS CO., INC.
K790520 04/18/1979 AIRCARE OXYGEN GENERATOR MEDICAL SERVICES OF AMERICA, INC.
K790462 04/16/1979 MEDTRONIC MODEL 6972 MEDTRONIC VASCULAR
K790497 04/10/1979 BACTERIOLOGICAL CULTURE MEDIA MICRO MEDIA LABORATORIES
K790193 04/23/1979 MIZZY SYRIJET MARK IV MIZZY, INC.
K790551 04/24/1979 TRANSPORT INCUBATOR NARCO AIR-SHIELDS
K790732 04/19/1979 VENTIMETER CONTROLLER NARCO AIR-SHIELDS
K790733 04/19/1979 VENTIMETER VENTILATOR NARCO AIR-SHIELDS
K790574 04/30/1979 EPIC D215 NATIONAL PATENT DEVELOPMENT CORP.
K790062 04/10/1979 IV ADMINISTRATION SET WITH BACKCHECK NATIONAL PATENT DEVELOPMENT CORP.
K790575 04/13/1979 TUBE, ARMORED TRACHEAL NATIONAL PATENT DEVELOPMENT CORP.
K790730 04/26/1979 NDM PAPER TAPE ECG ELECTRODE NDM CORP.
K790490 04/23/1979 NEIA-FERRITIN ENZYMEIMMUNASSAY KIT NEW ENGLAND IMMUNOLOGY ASSOC.
K790450 04/06/1979 NOVATEC PRM NOVATEC, INC.
K790071 04/02/1979 ENDOSCOPE AND ACCESSORIES OLYMPUS CORP.
K790521 04/10/1979 OREIA - DIGOXIN ORGANON, INC.
K782063 04/04/1979 PREGNANCY, SENSIDEX TUBE TEST ORTHO DIAGNOSTICS, INC.
K782166 04/04/1979 SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 ORTHO DIAGNOSTICS, INC.
K790740 04/26/1979 BS 66, UNIVERSAL BUCKY STAND PAUSCH CORP.
K790741 04/26/1979 COMPACT SYSTEM PAUSCH CORP.
K790743 04/23/1979 COORDINATUS, HORIZONTAL RADIOGRAPHOC PAUSCH CORP.
K790742 04/26/1979 KS-78 VERTICAL WALL CASSETTE HOLDER PAUSCH CORP.
K790409 04/24/1979 LOW DEAD SPACE INSULIN SYRINGE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K790489 04/23/1979 MICROVIEW PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K790547 04/03/1979 PRO-TAB PROFESSIONAL TAPE CO., INC.
K790739 04/26/1979 QUINTON MODEL 530X ECG DATA CART QUINTON, INC.
K790378 04/10/1979 REYNOLDS BLEACHING PROCESS REYNOLDS LABORATORIES
K790661 04/12/1979 PROTECTOR II RICHARD-ALLAN MEDICAL IND., INC.
K790660 04/12/1979 SURGICAL RULER RICHARD-ALLAN MEDICAL IND., INC.
K790682 04/11/1979 TONOTEST BLOOD PRESSURE DEVICE ROBERT BOSCH CORP.
K790442 04/04/1979 ISOTONIC DILUENT ROYCO INSTRUMENTS
K790291 04/10/1979 OPERATING ROOM SPECIMEN CONTAINER SAGE PRODUCTS, INC.
K790508 04/10/1979 TRAPEZIO-METACARPAL JOINT SPACER SCIENTIFIC DATA SYSTEMS ISRAEL, LTD.
K790379 04/10/1979 SEP-T-VAC SUCTION CANNISTER W/ TUBING SHERWOOD MEDICAL CO.
K782077 04/03/1979 LANCER ICE CUBE SHERWOOD MEDICAL INDUSTRIES
K790765 04/26/1979 MULTIGRAPH SIEMENS CORP.
K790681 04/13/1979 SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150 SIEMENS CORP.
K790688 04/23/1979 MEVATRON 67 SIEMENS MEDICAL LABORATORIES, INC.
K790423 04/04/1979 FACTOR V DEFICIENT SIGMA CHEMICAL CO.
K790506 04/09/1979 DAISCOPE & ACCESSORIES SIMONSEN & WEELS EFTF.
K790606 04/23/1979 CATHETERS, GREENLINE SUCTION SNYDER LABORATORIES, INC.
K790254 04/10/1979 FOLEY CATHETERIZATION TRAY SNYDER LABORATORIES, INC.
K790420 04/23/1979 SUCTION CONNECTING TUBING SNYDER LABORATORIES, INC.
K790253 04/10/1979 URINARY DRAINAGE BAG SNYDER LABORATORIES, INC.
K790419 04/23/1979 YANKAUER & POODLE SUCTION INSTRUMENTS SNYDER LABORATORIES, INC.
K790482 04/03/1979 MODEL 4107-2S, HEARING AID STARKEY LABORATORIES, INC.
K790481 04/03/1979 MODEL FS1 STARKEY LABORATORIES, INC.
K790651 04/10/1979 MODEL WC-3 HEARING AID STARKEY LABORATORIES, INC.
K790736 04/26/1979 EMIT-TOX SERUM BENZODIAZEPINE ASSAY SYVA CO.
K790764 04/26/1979 PACEMAKERS WITHOUT SILASTIC COATING TELECTRONICS, INC.
K790374 04/10/1979 GILLETTE HEAT WRAP THE GILLETTE COMPANY
K790639 04/23/1979 "GONAD SHIELD" THE MOCHLETT LABORATORIES, INC.
K790111 04/04/1979 ATOMIZER, FURNACE MODEL HGA-400 THE PERKIN-ELMER CORP.
K790652 04/04/1979 TOGUARD TOGARD, INC.
K790067 04/10/1979 FLOW DIALYZER, CF 2300 CAPILLARY TRAVENOL LABORATORIES, S.A.
K790480 04/03/1979 TULANE HEAT-PACK TULANE
K790278 04/04/1979 ANALYZER, CENTRIFUCHEM SYSTEM 400 UNION CARBIDE CORP.
K790336 04/04/1979 UNION CARBIDE CORP. COMPUTER INTERFACE UNION CARBIDE CORP.
K790296 04/12/1979 ELECTRODE, MODEL E7504 PREP II VALLEYLAB, INC.
K790332 04/10/1979 MODEL IV6000 INFUSION PUMP VALLEYLAB, INC.
K790077 04/30/1979 BIOSTIL # 3884 VENOSPITAL, INC.
K790424 04/30/1979 FLU-VEN 01510 VENOSPITAL, INC.
K790540 04/23/1979 RIA TEST KIT, CENTRIA DIGOXIN VENTREX LABORATORIES, INC.
K790447 04/23/1979 VENTRE/SEP FERRITIN RIA VENTREX LABORATORIES, INC.
K790685 04/23/1979 POSI-TOT VICTOREEN, INC.
K790438 04/10/1979 COLORANT VIVADENT (USA), INC.
K790439 04/10/1979 CONTACT RESIN VIVADENT (USA), INC.
K790610 04/23/1979 SIGMOIDOSCOPE TIPLESS WELCH ALLYN, INC.
K790486 04/23/1979 FLOZYME* URIC ACID REAGENT WORTHINGTON DIAGNOSTIC SYSTEMS
K790373 04/10/1979 IVAC 630 VOLUMETRIC INFUSION PUMP Y
K790465 04/12/1979 KNEE COMPRESSION HOOK SYSTEM ZIMMER, INC.
K790331 04/03/1979 ZIMMER SURGICAL INSTRUMENT LUBRICANT ZIMMER, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact