FDA 510(k) Applications Received During March, 1979

FDA 510(k) Number Submission Date Device Name Applicant Contact
K790479 03/08/1979 A-GENT IMMUNOGLOBULINE TEST SYSTEM ABBOTT LABORATORIES
K790543 03/22/1979 THE ABBOTT EXECUTIVE ABBOTT LABORATORIES
K790437 03/07/1979 TRACH CARE KIT ABCO DEALERS, INC.
K790608 03/29/1979 BL BILIRUBINOMETER ADVANCED INSTRUMENTS, INC.
K790611 03/29/1979 OSMOMETER MODEL 3W11 ADVANCED INSTRUMENTS, INC.
K790519 03/16/1979 ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 AMERICAN MEDICAL SYSTEMS, INC.
K790461 03/05/1979 T-3 UPTAKE (MAA) KIT AMERSHAM CORP.
K790617 03/29/1979 CARBOHYDRATE FERMENTATION MEDIA ANAEROBE SYSTEMS
K790622 03/29/1979 CHOPPED MEAT AGAR ANAEROBE SYSTEMS
K790621 03/29/1979 CHOPPED MEAT GLUCOSE MEDIUM ANAEROBE SYSTEMS
K790616 03/29/1979 ENRICHED THIOGLYCOLLATE MEDIUM ANAEROBE SYSTEMS
K790620 03/29/1979 LOMBARD DOWELL BROTH MEDIUMW/TH REONINE ANAEROBE SYSTEMS
K790619 03/29/1979 LOMBARD-DOWELL BROTH MEDIUM ANAEROBE SYSTEMS
K790624 03/29/1979 LOMBARD-DOWELL BROTH MEDIUM W/LACTATE ANAEROBE SYSTEMS
K790627 03/29/1979 LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID ANAEROBE SYSTEMS
K790626 03/29/1979 LOMBARD-DOWELL GLUCOSE AGAR ANAEROBE SYSTEMS
K790623 03/29/1979 LOMBARD-DOWELL MILK AGAR ANAEROBE SYSTEMS
K790628 03/29/1979 LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR ANAEROBE SYSTEMS
K790618 03/29/1979 LOMBARD-DOWELL STARCH AGAR ANAEROBE SYSTEMS
K790625 03/29/1979 PEPTONE-YEAST EXTRACT BROTH ANAEROBE SYSTEMS
K790613 03/29/1979 CHOPPED MEAT GLOCOSE STARCH MEDIUM ANEROBE SYSTEMS
K790615 03/29/1979 CHOPPED MEAT MEDIUM ANEROBE SYSTEMS
K790614 03/29/1979 LOMBARD-DOWELL MEDIUM WITH GLUCOSE ANEROBE SYSTEMS
K790468 03/05/1979 IMPLANTABLE HEART LEAD EXTENDER ARCO MEDICAL PRODUCTS CO.
K790436 03/07/1979 IMPLANTABLE HEART LEAD TERMINAL ADAPTER ARCO MEDICAL PRODUCTS CO.
K790549 03/20/1979 HEATING BLOCK, WAMPOLE 37 C ARMKEL, LLC.
K790513 03/15/1979 HLA-2000 BDT ENT.
K790553 03/19/1979 CHOLESTEROL KIT, HDL-DS BECKMAN INSTRUMENTS, INC.
K790645 03/30/1979 ENDOTOME BERKELEY BIO-ENGINEERING
K790576 03/28/1979 QUANTIMUNE T-4 FIA BIO-RAD
K790597 03/26/1979 SENSOMAT SIDEARM ADAPTER BIOCHEM INTERNATIONAL, INC.
K790469 03/05/1979 STREP BLOOD AGAR-5% SHEEP BLOOD BIOMEDIA, INC.
K790612 03/29/1979 NUTRIFLOW NASOGASTRIC FEEDING TUBE BIOSEARCH MEDICAL PRODUCTS, INC.
K790478 03/09/1979 BROWNE MODEL UD-4DE BROWNE CORP.
K790556 03/19/1979 CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC CALBIOCHEM-BEHRING CORP.
K790460 03/05/1979 TXOCELL-IHA REAGENT SYSTEM CALBIOCHEM-BEHRING CORP.
K790509 03/15/1979 CARDIOCASSETTE II, AMBULATORY ECG SYSTEM CAMBRIDGE INSTRUMENTS, INC.
K790566 03/19/1979 PACEMAKER, OVALITH-D CARDIAC CARATOMIC
K790503 03/13/1979 CARDIOTEST 2200 CARDIAC PACEMAKERS, INC.
K790432 03/02/1979 MICROLITH MODELS 505;605;507;607;703;803 CARDIAC PACEMAKERS, INC.
K790644 03/30/1979 "SUBMAX" CHASE MFG. CO.
K790535 03/21/1979 CLAYTON COLON CLEANSING KIT CLAYTON MEDICAL PRODUCTS, INC.
K790546 03/20/1979 FLOWMETER, OPTIFLO GAS COBE LABORATORIES, INC.
K790483 03/09/1979 "COULTER ACCU-ZYME II GOT REAGENT" COULTER ELECTRONICS, INC.
K790522 03/09/1979 COULTER ACCU-ZYME II GPT REAGENT COULTER ELECTRONICS, INC.
K790579 03/27/1979 MEDISTOR II CYBERMEDIC, INC.
K790571 03/23/1979 QUIK-STAIN DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790515 03/15/1979 BEHIND-THE-EAR HEARING AID DANAVOX, INC.
K790539 03/20/1979 HEARING AID DANAVOX 775V DANAVOX, INC.
K790524 03/15/1979 DATA-ZYME ACIA PHOSPHATASE PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K790457 03/05/1979 HEMOGLOBIN CONTROLS DATA MEDICAL ASSOCIATES, INC.
K790589 03/27/1979 DENTURE-TIGHT DEN-MAT CORP.
K790641 03/30/1979 GDC-685 DERINGER-NEY INC.
K790538 03/20/1979 SPONGE COUNTER DEVON INDUSTRIES, INC.
K790514 03/15/1979 I NETILMICIN RIA KIT DIAGNOSTIC PRODUCTS CORP.
K790564 03/19/1979 ADAPTER-STRAIGHT DLP, INC.
K790563 03/19/1979 ADAPTERS-Y-TYPE DLP, INC.
K790565 03/19/1979 AORTIC ROOT CANNULA DLP, INC.
K790459 03/05/1979 CEMENT DISPENSER CEMENT MIXER DOW CORNING WRIGHT
K790504 03/13/1979 "SANDEE" SANDING BLOCK DR. BERTRAM L. STEEL
K790502 03/13/1979 DYONICS STEROTOXIC POSITIONER DYONICS, INC.
K790477 03/09/1979 TY RIA KIT, AUTOMATED ASSAY SYSTEM E. R. SQUIBB & SONS, INC.
K790640 03/30/1979 HOWMEDICA BRASS CENTER DISC E.C. MOORE CO.
K790491 03/08/1979 ITIMIZED INSTRUMENTS E.M. ADAMS
K790629 03/29/1979 KODAK GRAY TONE IMAGING FILM EASTMAN KODAK COMPANY
K790452 03/05/1979 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS EDWARDS PACEMAKER SYSTEMS
K790562 03/19/1979 PULSE GENERATOR MODEL 61 AND 128 ELA MEDICAL, INC.
K790444 03/06/1979 ELECATH MULTI-PURPOSE ARTERIAL SURGER ELECTRO-CATHETER CORP.
K790602 03/27/1979 RIA, DIGNXIN-125-I ENDOCRINE-METABOLIC CENTER
K790630 03/27/1979 RIA, INSULIN, DOUBLE ANTIBODY ENDOCRINE-METABOLIC CENTER
K790499 03/13/1979 MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER ENGINEERING DYNAMICS CORP.
K790545 03/20/1979 STRESS TESTING SYSTEM, LATERAL TILTING ENGINEERING DYNAMICS CORP.
K790544 03/22/1979 STRESS TESTING SYSTEM, MULTI-POSITION ENGINEERING DYNAMICS CORP.
K790466 03/05/1979 U-MAT ENGINEERING DYNAMICS CORP.
K790554 03/19/1979 EXETER LIP SEAL EXETER MEDICAL LABS, INC.
K790525 03/15/1979 HEMATROL S HEMATOLOGY CONTROLS FISHER SCIENTIFIC CO., LLC.
K790498 03/13/1979 LISS REAGENT FISHER SCIENTIFIC CO., LLC.
K790578 03/27/1979 GAMMA SMAC REAGENTS GAMMA ENTERPRISES, INC.
K790448 03/02/1979 EASYFIL GENERAL REFINERIES, INC.
K790511 03/16/1979 MOBILE X-RAY UNIT GENERAL X-RAY, INC.
K790443 03/07/1979 PORTABLE X-RAY UNIT GENERAL X-RAY, INC.
K790512 03/16/1979 PORTABLE X-RAY UNIT GENERAL X-RAY, INC.
K790451 03/05/1979 X-RAY UNITS, GX-101, UCIS-510 AND GX-111 GENERAL X-RAY, INC.
K790609 03/29/1979 AUDIOMETER GRASON-STADLER, INC.
K790534 03/13/1979 MERSILENE SUTURES HANCOCK LABORATORIES, INC.
K790537 03/20/1979 AUTOMATIC ELECTRONIC SPHYMOMONOMETER HEALTHCARE ENTERPRISES, INC.
K790646 03/30/1979 HELENA "QUIPLATE" SYSTEM HELENA LABORATORIES
K790583 03/27/1979 QUIK COLUMN METHODOLOGY HELENA LABORATORIES
K790454 03/05/1979 MODEL 78801A PATIENT MONITORS HEWLETT-PACKARD CO.
K790536 03/22/1979 CLEARVIEW HIPOINT RESEARCH, INC.
K790485 03/12/1979 AMYLOCHROME STAT SEPARATOR, TEST HOFFMANN-LA ROCHE, INC.
K790600 03/26/1979 HOWMEDICA STRIP CROWN HOWMEDICA CORP.
K790501 03/13/1979 PEDIATRIC OSTEOTOMY SYSTEM HOWMEDICA CORP.
K790598 03/26/1979 RUWA FINISHING STRIPS HOWMEDICA CORP.
K790599 03/26/1979 RUWA MATRIX STRIPS HOWMEDICA CORP.
K790572 03/23/1979 LOUNGE, TILT-A-BODY STRETCH INNOVATIVE PRODUCTS, INC.
K790548 03/20/1979 ENDOCARDIAL PACING LEAD, MODEL 476-01 INTERMEDICS, INC.
K790464 03/05/1979 FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO INTL. DIAGNOSTIC TECHNOLOGY
K790476 03/05/1979 QUICKSCAN HOLTER II INTL. MEDICAL, INC.
K790577 03/28/1979 HEMORRHOIDAL LIGATOR J. SKLAR MFG. CO., INC.
K790471 03/05/1979 JELCO* DISC FILTER-0.2 MICRON JELCO LABORATORIES
K790433 03/02/1979 NATURDOM JUAN C. LUCENA
K790588 03/27/1979 ASSAY REAGENTS, LSA 290 KALLESTAD LABORATORIES, INC.
K790586 03/27/1979 CHEMBOND L.D. CAULK CO.
K790585 03/27/1979 FINESSE L.D. CAULK CO.
K790526 03/15/1979 LIO-714 OPACITYMETER LASER INDUSTRIES LTD.
K790605 03/29/1979 RESPIRAOTR, CAM-10 RBL LIFECARE SERVICES, INC.
K790559 03/19/1979 ALARM MADDAK, INC.
K790531 03/15/1979 ANUS STIMULATOR MADDAK, INC.
K790527 03/15/1979 BURNETT-KETCHUM DYNAMIC HAND EXERCISER MADDAK, INC.
K790587 03/27/1979 CANVAS WEDGE MADDAK, INC.
K790558 03/19/1979 CERSA-CANE MADDAK, INC.
K790557 03/19/1979 CRUTCH MADDAK, INC.
K790532 03/15/1979 FEVER TESTER MADDAK, INC.
K790561 03/19/1979 OFFSET ALUMINUM CANE MADDAK, INC.
K790530 03/15/1979 PUSH BALL INCLINE MADDAK, INC.
K790560 03/19/1979 ROLLCHAIR, ORTHO BUCKET SEAT MADDAK, INC.
K790528 03/15/1979 THERAPY GYROSCOPE MADDAK, INC.
K790529 03/15/1979 WALKING AID MADDAK, INC.
K790455 03/05/1979 MICROFLUSH MEDEX, INC.
K790430 03/02/1979 MEDICA II-F-ASMA TEST KIT MEDICA CORP.
K790520 03/16/1979 AIRCARE OXYGEN GENERATOR MEDICAL SERVICES OF AMERICA, INC.
K790467 03/05/1979 SURGICAL EYE SPONGE MEDTECH INTL., INC.
K790429 03/02/1979 MEDTRONIC MODEL 6957 MEDTRONIC VASCULAR
K790462 03/05/1979 MEDTRONIC MODEL 6972 MEDTRONIC VASCULAR
K790463 03/05/1979 MODU-SET COLLIMOTOR MEDTRONIC VASCULAR
K790642 03/30/1979 LEY ELECTRO-SURGICAL UNITS MERCED MEDICAL, INC.
K790497 03/13/1979 BACTERIOLOGICAL CULTURE MEDIA MICRO MEDIA LABORATORIES
K790584 03/27/1979 AMES TDA/GENTGMICIN MILES LABORATORIES, INC.
K790581 03/27/1979 CHROMATOGRAPHY TUBES MILES LABORATORIES, INC.
K790445 03/05/1979 ULTRA-FREE MILLIPORE CORP.
K790580 03/27/1979 RIA KIT, PROSTATIC ACID MONITOR SCIENCE CORP.
K790552 03/20/1979 AS7 & AS8 MONITORS NARCO AIR-SHIELDS
K790551 03/20/1979 TRANSPORT INCUBATOR NARCO AIR-SHIELDS
K790456 03/06/1979 SERIES 7000 NARCO MCKESSON CO.
K790472 03/05/1979 BURRON VENTED NEEDLE NATIONAL PATENT DEVELOPMENT CORP.
K790574 03/23/1979 EPIC D215 NATIONAL PATENT DEVELOPMENT CORP.
K790575 03/23/1979 TUBE, ARMORED TRACHEAL NATIONAL PATENT DEVELOPMENT CORP.
K790490 03/08/1979 NEIA-FERRITIN ENZYMEIMMUNASSAY KIT NEW ENGLAND IMMUNOLOGY ASSOC.
K790570 03/23/1979 STIMULATOR, NIC-106 VISUAL NICOLET BIOMEDICAL INSTRUMENTS
K790604 03/19/1979 CUSTOM TUBING SETS NORTON PERFORMANCE PLASTICS CORP.
K790450 03/05/1979 NOVATEC PRM NOVATEC, INC.
K790521 03/16/1979 OREIA - DIGOXIN ORGANON, INC.
K790428 03/01/1979 MDL-201A & T DL-201A PULSE GENERATOR PACESETTER SYSTEMS
K790638 03/30/1979 ACCUTRON POLLUTION REDUCER PARKER LABORATORIES, INC.
K790555 03/19/1979 HEMO-WEDGE PARKER LABORATORIES, INC.
K790489 03/12/1979 MICROVIEW PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K790547 03/20/1979 PRO-TAB PROFESSIONAL TAPE CO., INC.
K790442 03/07/1979 ISOTONIC DILUENT ROYCO INSTRUMENTS
K790508 03/09/1979 TRAPEZIO-METACARPAL JOINT SPACER SCIENTIFIC DATA SYSTEMS ISRAEL, LTD.
K790492 03/13/1979 SERO-STAT STREPTOCOCCUS TEST SCOTT LABORATORIES, INC.
K790440 03/07/1979 PROGESTERONE SERONO LABORATORIES, INC.
K790523 03/15/1979 ARGYLE ESOPHAGEAL STETHOSCOPE SHERWOOD MEDICAL INDUSTRIES
K790425 03/02/1979 IONESCU-SHILEY COMPOSITE CONDUIT-PULMONI SHILEY, INC.
K790423 03/01/1979 FACTOR V DEFICIENT SIGMA CHEMICAL CO.
K790507 03/13/1979 800 ECG ELECTRODE SIMONSEN & WEELS EFTF.
K790506 03/13/1979 DAISCOPE & ACCESSORIES SIMONSEN & WEELS EFTF.
K790606 03/29/1979 CATHETERS, GREENLINE SUCTION SNYDER LABORATORIES, INC.
K790607 03/29/1979 GREENLINE IRRIGATION TRAYS SNYDER LABORATORIES, INC.
K790542 03/22/1979 ELECTRODES, STAODERM STERILE STAODYNAMICS, INC.
K790482 03/08/1979 MODEL 4107-2S, HEARING AID STARKEY LABORATORIES, INC.
K790481 03/08/1979 MODEL FS1 STARKEY LABORATORIES, INC.
K790431 03/02/1979 TREATED BARRIER INCISE DRAPE SURGIKOS, INC.
K790495 03/13/1979 THYROXINE RIA KIT TECHNIA DIAGNOSTICS LTD.
K790639 03/30/1979 "GONAD SHIELD" THE MOCHLETT LABORATORIES, INC.
K790533 03/15/1979 HD CAPILLARY FILM DIALYZER, MODEL 1001 TRAVENOL LABORATORIES, S.A.
K790591 03/26/1979 HEMODIALYSIS BLOOD CIRCUIT TRAVENOL LABORATORIES, S.A.
K790480 03/08/1979 TULANE HEAT-PACK TULANE
K790550 03/20/1979 CENTRIA SYSTEM UNION CARBIDE CORP.
K790643 03/30/1979 CENTRIFICHEM FILTER CALIBRATION SET UNION CARBIDE CORP.
K790424 03/01/1979 FLU-VEN 01510 VENOSPITAL, INC.
K790540 03/20/1979 RIA TEST KIT, CENTRIA DIGOXIN VENTREX LABORATORIES, INC.
K790447 03/05/1979 VENTRE/SEP FERRITIN RIA VENTREX LABORATORIES, INC.
K790601 03/26/1979 DENTAL HANDPIECE VENTURE TECHNOLOGY, INC.
K790438 03/07/1979 COLORANT VIVADENT (USA), INC.
K790439 03/07/1979 CONTACT RESIN VIVADENT (USA), INC.
K790488 03/12/1979 INTERPLANTA SP TOTAL HIP PROSTHESIS WALDEMAR LINK GMBH & CO. KG
K790595 03/26/1979 DENTAL ALGINATE IMPRESSION MATERIAL WALLACE A. ERICKSON & CO.
K790593 03/26/1979 DENTAL CEMENT, ZINC PHOSPHATE WALLACE A. ERICKSON & CO.
K790594 03/26/1979 DENTAL COMPOSITE RESTORATIVE MATERIAL WALLACE A. ERICKSON & CO.
K790596 03/26/1979 ENAMEL BOND SYSTEM WALLACE A. ERICKSON & CO.
K790592 03/26/1979 IMPRESSION MATERIAL, RUBBER WALLACE A. ERICKSON & CO.
K790610 03/29/1979 SIGMOIDOSCOPE TIPLESS WELCH ALLYN, INC.
K790496 03/13/1979 BIOBRANE BRAND TEMPORARY WOUND DRESSING WOODROOF LABORATORIES, INC.
K790470 03/05/1979 "THE GUARDIAN" SPHYGMOMANOMETER WORLD BOOK ENCYCLOPEDIA, INC.
K790486 03/12/1979 FLOZYME* URIC ACID REAGENT WORTHINGTON DIAGNOSTIC SYSTEMS
K790474 03/05/1979 SZAMYL 6.5 WORTHINGTON DIAGNOSTIC SYSTEMS
K790582 03/27/1979 INTRAVASCULAR ADMINISTRATION SET Y
K790465 03/05/1979 KNEE COMPRESSION HOOK SYSTEM ZIMMER, INC.


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