FDA 510(k) Decisions During May, 1979  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K790850 05/31/1979 T.E.N.S.* SINGLE-USE ELECTRODE 3M COMPANY
K782008 05/14/1979 DRESSING, ENVIRON WOUND ABBOTT LABORATORIES
K790731 05/08/1979 OXYGEN HUMIDIFIER KIT ABBOTT LABORATORIES
K790543 05/03/1979 THE ABBOTT EXECUTIVE ABBOTT LABORATORIES
K790633 05/17/1979 "ACCOR" MATRIX ACCOR, INC.
K790809 05/04/1979 VS, ANESTHESIA VENTILATOR AIRCO/OHIO MEDICAL PRODUCTS
K790889 05/17/1979 CIRCUIT, BREATHING (W CONNEC, Y PIECE) AIRLIFE, INC.
K790886 05/17/1979 CORRUGATED FLEXIBLE POLYETHYLENE AIRLIFE, INC.
K790884 05/17/1979 FACE TENT-VINYL AIRLIFE, INC.
K790885 05/17/1979 NASAL, OXYGEN, CANNULA AIRLIFE, INC.
K790847 05/25/1979 EGS MODEL 300 ALFRED V. GRECO
K790519 05/14/1979 ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 AMERICAN MEDICAL SYSTEMS, INC.
K790461 05/03/1979 T-3 UPTAKE (MAA) KIT AMERSHAM CORP.
K790627 05/01/1979 LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID ANAEROBE SYSTEMS
K790625 05/01/1979 PEPTONE-YEAST EXTRACT BROTH ANAEROBE SYSTEMS
K790799 05/31/1979 PULPTESTER MODEL 2001 ANALYTIC TECHNOLOGY
K790322 05/14/1979 OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 APPLIED MEDICAL RESEARCH
K790436 05/14/1979 IMPLANTABLE HEART LEAD TERMINAL ADAPTER ARCO MEDICAL PRODUCTS CO.
K790549 05/03/1979 HEATING BLOCK, WAMPOLE 37 C ARMKEL, LLC.
K790770 05/18/1979 SAFETY HOLSTER, SINGLE-USE ASPEN LABORATORIES, INC.
K790899 05/23/1979 BACTEC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K790513 05/31/1979 HLA-2000 BDT ENT.
K790308 05/01/1979 DISPOSABLE DIALYZERS, SD-ID, SD-2D BENTLEY LABORATORIES, INC.
K790360 05/22/1979 QUANTAZYME TOXOPLASMA BIO-RAD
K790769 05/03/1979 BETA/PAK BIO/DATA CORP.
K790762 05/14/1979 PLATFORM TCCK TOTAL KNEE BIOMET, INC.
K790872 05/23/1979 ENTERIC TUBE GUIDE BIOSEARCH MEDICAL PRODUCTS, INC.
K790612 05/11/1979 NUTRIFLOW NASOGASTRIC FEEDING TUBE BIOSEARCH MEDICAL PRODUCTS, INC.
K790120 05/07/1979 SLENDERTONE BLOOMEX INTERNATIONAL, INC.
K790856 05/29/1979 PROCTOSCOPE #501 C. INTL.
K790556 05/07/1979 CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC CALBIOCHEM-BEHRING CORP.
K790460 05/25/1979 TXOCELL-IHA REAGENT SYSTEM CALBIOCHEM-BEHRING CORP.
K790503 05/17/1979 CARDIOTEST 2200 CARDIAC PACEMAKERS, INC.
K790677 05/07/1979 EO EVACUATING SYSTEM I CASTLE CO.
K790801 05/03/1979 STERILE DEFIBRINATED SHEEP BLOOD CENTRAL BIOLOGICAL CO.
K790546 05/11/1979 FLOWMETER, OPTIFLO GAS COBE LABORATORIES, INC.
K790690 05/16/1979 OMNI-STANICOR-(THETA) MODEL 217 CORDIS CORP.
K790483 05/03/1979 "COULTER ACCU-ZYME II GOT REAGENT" COULTER ELECTRONICS, INC.
K790522 05/01/1979 COULTER ACCU-ZYME II GPT REAGENT COULTER ELECTRONICS, INC.
K790869 05/17/1979 "CARDIO-SLIDECOMP" CREATIVE INSTRUMENTS
K790810 05/25/1979 DISPOSA-CUF CREST MEDICAL EQUIPMENT
K790776 05/23/1979 DADE LOW IONIC STRENGTH SOLUITION (LISS) DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790767 05/23/1979 IMMU-TEK AUTOMATIC CENTRIFUGE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790524 05/23/1979 DATA-ZYME ACIA PHOSPHATASE PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K790343 05/01/1979 DATA-ZYME CK CALORIMETRIC/UV PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K790668 05/23/1979 VENOUS PRESSURE MONITOR, MF 35 LF DECO MEDICAL, INC.
K790941 05/23/1979 D.T.T. LOCK SCREW INSERTER DEPUY, INC.
K790641 05/01/1979 GDC-685 DERINGER-NEY INC.
K790820 05/04/1979 NON-REBREATHING "T" PIECE DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
K790514 05/03/1979 I NETILMICIN RIA KIT DIAGNOSTIC PRODUCTS CORP.
K790672 05/31/1979 ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU DIAGNOSTICA, INC.
K790671 05/31/1979 DERMATOPHYTIN "O" DIAGNOSTICA, INC.
K790640 05/01/1979 HOWMEDICA BRASS CENTER DISC E.C. MOORE CO.
K790452 05/08/1979 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS EDWARDS PACEMAKER SYSTEMS
K790562 05/08/1979 PULSE GENERATOR MODEL 61 AND 128 ELA MEDICAL, INC.
K790794 05/31/1979 SIEMENS CARDIOSTAT 701 ELMED, INC.
K790382 05/02/1979 COIL DIALYSIS, MODELS DM-360 AND DM-360- ESTRACORPOREAL, INC.
K790578 05/15/1979 GAMMA SMAC REAGENTS GAMMA ENTERPRISES, INC.
K790372 05/03/1979 H-D-EL GENERAL DIAGNOSTICS
K790687 05/03/1979 BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2 GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K790771 05/15/1979 LD-P REAGENT (LDH P-L REAGENT) GILFORD DIAGNOSTICS
K790846 05/17/1979 MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) GRASON-STADLER, INC.
K790871 05/14/1979 ENCLOSED CASE CART HAMILTON INDUSTRIES, INC.
K790537 05/08/1979 AUTOMATIC ELECTRONIC SPHYMOMONOMETER HEALTHCARE ENTERPRISES, INC.
K790737 05/16/1979 HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID HEARING SERVICES, INC.
K790826 05/31/1979 COAGULATION ARP HELENA LABORATORIES
K790646 05/23/1979 HELENA "QUIPLATE" SYSTEM HELENA LABORATORIES
K790365 05/11/1979 FLUID MEASUREMENT STAND HEWLETT-PACKARD CO.
K790485 05/03/1979 AMYLOCHROME STAT SEPARATOR, TEST HOFFMANN-LA ROCHE, INC.
K790849 05/11/1979 H-H FIXATION AND JOINING CONNECTORS HOLTER-HAUSNER INTL.
K790825 05/31/1979 LS-8 VISICORDER HONEYWELL, INC.
K790600 05/21/1979 HOWMEDICA STRIP CROWN HOWMEDICA CORP.
K790598 05/21/1979 RUWA FINISHING STRIPS HOWMEDICA CORP.
K790599 05/21/1979 RUWA MATRIX STRIPS HOWMEDICA CORP.
K790249 05/16/1979 TEST CELLS HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K790669 05/14/1979 DROP CONTROLLER IMED CORP.
K790674 05/14/1979 "THE SURGICAL ASSISTANT" INSTRUMENT MAKAR, INC.
K790320 05/18/1979 DELTA-LITE JOHNSON & JOHNSON PROFESSIONALS, INC.
K790085 05/29/1979 KAGER TRAPDUST KAGER INTL.
K790588 05/15/1979 ASSAY REAGENTS, LSA 290 KALLESTAD LABORATORIES, INC.
K790636 05/08/1979 KIMLON UNIVERSAL DRAPE KIMBERLY-CLARK CORP.
K790586 05/16/1979 CHEMBOND L.D. CAULK CO.
K790585 05/16/1979 FINESSE L.D. CAULK CO.
K790397 05/23/1979 CONCEP-7-B-HCG LEECO DIAGNOSTICS, INC.
K790532 05/29/1979 FEVER TESTER MADDAK, INC.
K790726 05/01/1979 BEHIND-THE-EAR HEARING INSTRUMENT, H54 MARCON HEARING INSTRUMENTS, INC.
K790700 05/01/1979 BEHIND-THE-EAR HEARING INSTRUMENT, H56 MARCON HEARING INSTRUMENTS, INC.
K790727 05/01/1979 BEHIND-THE-EAR, MODEL H37D MARCON HEARING INSTRUMENTS, INC.
K790779 05/16/1979 MODEL H39C-BEHING-THE-EAR HEARING INSTRU MARCON HEARING INSTRUMENTS, INC.
K790697 05/01/1979 MODEL H58-BEHIND-THE-EAR HEARING INSTR. MARCON HEARING INSTRUMENTS, INC.
K790815 05/15/1979 CULTURETTE BRAND PVA MARION LABORATORIES, INC.
K790407 05/16/1979 MICROTEC BACTERIAL FILTER MEDEX, INC.
K790295 05/25/1979 TEST KIT, IIF-AMA MEDICA CORP.
K790758 05/08/1979 HEMOCLEAR U-NEPHROS 1.0 DIALYZER MEDICAL, INC.
K790766 05/25/1979 MEDTRONIC MODELS 6907/6901 MEDTRONIC VASCULAR
K790790 05/25/1979 PISCES-SELECTOR X MEDTRONIC VASCULAR
K790928 05/21/1979 3-WAY "T" 22MM MALE MEM MEDICAL, INC.
K790932 05/21/1979 AEROSOL MOUTHPIECE NO. M-091 MEM MEDICAL, INC.
K790931 05/21/1979 CORRUGATED TUBE WITH MOUTHPIECE MEM MEDICAL, INC.
K790929 05/21/1979 DRAINAGE BAG MEM MEDICAL, INC.
K790933 05/21/1979 MOUTHPIECE M-187 MEM MEDICAL, INC.
K790924 05/21/1979 NEBULIZER NO. M-175 MEM MEDICAL, INC.
K790925 05/21/1979 NEBULIZER WITH 4-WAY T NO M-174 MEM MEDICAL, INC.
K790926 05/21/1979 NEBULIZER WITH MOUTHPIECE AND TEE MEM MEDICAL, INC.
K790934 05/21/1979 OXYGEN BARB M-552 MEM MEDICAL, INC.
K790927 05/21/1979 OXYGENERATOR NO. M-049 MEM MEDICAL, INC.
K790642 05/08/1979 LEY ELECTRO-SURGICAL UNITS MERCED MEDICAL, INC.
K790665 05/15/1979 NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790581 05/15/1979 CHROMATOGRAPHY TUBES MILES LABORATORIES, INC.
K790580 05/25/1979 RIA KIT, PROSTATIC ACID MONITOR SCIENCE CORP.
K790552 05/01/1979 AS7 & AS8 MONITORS NARCO AIR-SHIELDS
K790817 05/07/1979 RIA KIT, QUANTITATION OF PROSTATIC ACID NEW ENGLAND NUCLEAR
K790570 05/23/1979 STIMULATOR, NIC-106 VISUAL NICOLET BIOMEDICAL INSTRUMENTS
K790282 05/04/1979 ELDONCARD NORDISK INFUSER SYSTEM
K790843 05/31/1979 SNAP-WAY NORTHWEST ORTHODONTICS, INC.
K790604 05/04/1979 CUSTOM TUBING SETS NORTON PERFORMANCE PLASTICS CORP.
K790673 05/04/1979 OMNIMEDICAL AUTOMATIC 1001 OMNIMEDICAL
K790729 05/01/1979 OCTAGONAL ALUMINUM FRAMING SYSTEM ORTHOPEDIC SYSTEMS, INC.
K790861 05/07/1979 MOIRE CONTOURGRAPH, MODELS MS-1, SS-1 OTAL PRECISION CO. LTD.
K790638 05/25/1979 ACCUTRON POLLUTION REDUCER PARKER LABORATORIES, INC.
K790959 05/31/1979 LIFEPATCH ECG ELECTRODES PHYSIO-CONTROL CORP.
K790860 05/29/1979 RT-HOOD PLASTICS SUPPLIES & PRODUCTS
K790421 05/15/1979 ROCHE LACTATE ANALYZER 640 ROCHE MEDICAL ELECTRONICS, INC.
K790858 05/15/1979 PERMOBIL EXTERIOR SAAB-SCANIA OF AMERICA, INC.
K790859 05/15/1979 PERMOBIL SUPERIOR SAAB-SCANIA OF AMERICA, INC.
K790684 05/18/1979 COLOR CODING OF SURGICAL INSTRUMENTS SARA DAN, INC.
K790492 05/01/1979 SERO-STAT STREPTOCOCCUS TEST SCOTT LABORATORIES, INC.
K790746 05/14/1979 THE "BIONIC EXERCISER" SCUDDER MOLNER INSTRUMENTS
K790679 05/23/1979 ESTRADIOL RIA KIT SERONO LABORATORIES, INC.
K790440 05/03/1979 PROGESTERONE SERONO LABORATORIES, INC.
K790783 05/07/1979 KOORDINAT 3D SIEMENS CORP.
K790747 05/04/1979 MEVATRON 74 SIEMENS MEDICAL LABORATORIES, INC.
K790724 05/23/1979 ENZYMATIC DETERMINATION SIGMA CHEMICAL CO.
K790760 05/23/1979 REAGENT SYSTEM #350HDL, SIGMA PROCEDURE SIGMA CHEMICAL CO.
K790507 05/18/1979 800 ECG ELECTRODE SIMONSEN & WEELS EFTF.
K790607 05/11/1979 GREENLINE IRRIGATION TRAYS SNYDER LABORATORIES, INC.
K790678 05/11/1979 INTRAUTERINE CATHETER TIP SONICAID, INC.
K790837 05/16/1979 ARRHYTHMIA II CARDULE SPACELABS, INC.
K790877 05/23/1979 BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO STACKHOUSE ASSOC.
K790542 05/23/1979 ELECTRODES, STAODERM STERILE STAODYNAMICS, INC.
K790904 05/18/1979 STAO-HOTPACK STAODYNAMICS, INC.
K790745 05/01/1979 _MODEL WC-1 BEHIND-THE-EAR HEARING AID STARKEY LABORATORIES, INC.
K790802 05/01/1979 ESSAR TOURNIQUET FOR VENIPUNCTURE STEWART RESEARCH, INC.
K790725 05/11/1979 BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* SURGIKOS, INC.
K790804 05/25/1979 PURGE LINE UNIT SURGIKOS, INC.
K790431 05/04/1979 TREATED BARRIER INCISE DRAPE SURGIKOS, INC.
K790686 05/25/1979 EMIT CFA THYROXINE ASSAY SYVA CO.
K790829 05/15/1979 EMIT GENTAMICIN ASSAY SYVA CO.
K790830 05/15/1979 EMIT GENTAMICIN CONTROL SYVA CO.
K790735 05/03/1979 EMIT-TOX SERUM CALIBRATORS SYVA CO.
K790495 05/03/1979 THYROXINE RIA KIT TECHNIA DIAGNOSTICS LTD.
K790867 05/31/1979 CARDIAC PULSE GENERATOR, 16 SERIES TELECTRONICS, INC.
K790868 05/25/1979 GENERATOR, 16 SERIES, MODIFIED TOP CAP TELECTRONICS, INC.
K790105 05/24/1979 TERUMO IMUGARD TERUMO AMERICA, INC.
K790912 05/21/1979 ARIDYNE 3500 TIMETER INSTRUMENT CORP.
K790903 05/31/1979 TRACOR MODEL RA-411 MICROPROCESSOR TRACOR INSTRUMENTS, INC.
K790315 05/15/1979 BLOOD CELL SEPARATOR SYSTEM CS3000 TRAVENOL LABORATORIES, S.A.
K790533 05/02/1979 HD CAPILLARY FILM DIALYZER, MODEL 1001 TRAVENOL LABORATORIES, S.A.
K790591 05/02/1979 HEMODIALYSIS BLOOD CIRCUIT TRAVENOL LABORATORIES, S.A.
K790550 05/07/1979 CENTRIA SYSTEM UNION CARBIDE CORP.
K790643 05/23/1979 CENTRIFICHEM FILTER CALIBRATION SET UNION CARBIDE CORP.
K790662 05/15/1979 CENTRIFICHEM INORGANIC PHOSPHORUS UNION CARBIDE CORP.
K790750 05/14/1979 COLOSTOMY DEVICE W/ PRESSURE LID VABAR CORP.
K790749 05/16/1979 COLOSTOMY ENEMA DEVICE VABAR CORP.
K790780 05/03/1979 ATOMIC ABSORPTION SPECTROPHOTOMETER, VARIAN ASSOC., INC.
K790781 05/03/1979 SPECTROPHOTOMETER SYSTEM, MODEL AA-475 VARIAN ASSOC., INC.
K790601 05/31/1979 DENTAL HANDPIECE VENTURE TECHNOLOGY, INC.
K790689 05/29/1979 REVISED BATTERY CHARGER VICKERS AMERICA MEDICAL CORP.
K790768 05/23/1979 WAKO CHOLESTEROL TEST WAKO INTL., INC.
K790496 05/03/1979 BIOBRANE BRAND TEMPORARY WOUND DRESSING WOODROOF LABORATORIES, INC.
K790474 05/01/1979 SZAMYL 6.5 WORTHINGTON DIAGNOSTIC SYSTEMS
K790582 05/29/1979 INTRAVASCULAR ADMINISTRATION SET Y
K790317 05/07/1979 PAP RIA KIT YANG LABORATORIES, INC.
K790104 05/14/1979 PISTORMATIC ZELBY, BURSTEIN, HARTMAN & BURSTEIN
K790219 05/08/1979 PROTHESIS, RETAINED GEOMETRIC KNEE ZIMMER, INC.


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