FDA 510(k) Decisions During September, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K771653 09/12/1977 ELECTRONIC STETHOSCOPE 3M COMPANY
K771547 09/20/1977 PETITES BETWEEN-PERIOD PROTECTORS 3M COMPANY
K771764 09/30/1977 CORONARY PRESSURE PERFUSION PUMP 3M HEALTH CARE, SARNS
K771608 09/15/1977 A-GENT TRIGLYCERIDES ABBOTT LABORATORIES
K771593 09/12/1977 I.V. PUMP SET FOR FAT EMULSION ABBOTT LABORATORIES
K771594 09/28/1977 PRIMARY PIGGYBACK VENOSET W/ FILTER ABBOTT LABORATORIES
K771656 09/22/1977 PROLACTIN RIA DIAG. KIT ABBOTT LABORATORIES
K771671 09/12/1977 AUDITORY TRAINER ACCUTONE, INC.
K771586 09/15/1977 CHOLOPAP-HDL ADVANCED BIOMEDICAL METHODS, INC.
K771668 09/14/1977 DISP. FLUID ISOLATOR & PRESS. RELIEF AILTECH
K771049 09/12/1977 ENDOSCOPIC TRAY AMERICAN HOSPITAL SUPPLY CORP.
K771699 09/13/1977 CARA-STAIN MODEL 3000 AMERICAN SAFETY EQUIPMENT CORP.
K771616 09/02/1977 API 20A ANALYTICAL PRODUCTS, INC.
K771585 09/13/1977 T3 UPTAKE DIAG. KIT ANTIBODIES INC.
K771007 09/30/1977 ELECTROSURGICAL POWER GENERATORS ASPEN LABORATORIES, INC.
K771696 09/15/1977 EMODIALYSIS DEL. SYS. MODEL 7110 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771582 09/13/1977 HOLESTEROL DELTA TEST ASSAY BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771628 09/20/1977 NSULIN RIA KIT 125I BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771603 09/15/1977 IMMOCHEMISTRY SYSTEM BECKMAN INSTRUMENTS, INC.
K771369 09/14/1977 LIQ. SCINTILLATION SPECTROPHOTOMETEO BECKMAN INSTRUMENTS, INC.
K771733 09/28/1977 8" EMESIS BASIN BEMIS HEALTH CARE
K771738 09/28/1977 MALE URINAL BEMIS HEALTH CARE
K771689 09/14/1977 DIAL X COLLIMATOR MODEL A&B BENNETT X-RAY CORP.
K771711 09/28/1977 BIOTOME BERKELEY BIO-ENGINEERING
K771644 09/26/1977 FRAGMATOME MODEL 820 BERKELEY BIO-ENGINEERING
K771270 09/12/1977 BLOOD ADMINISTRATION TYPE R BERMAN, PCP & CONSULTANTS, INC.
K771269 09/12/1977 BLOOD COLLECTION SET TYPE H BERMAN, PCP & CONSULTANTS, INC.
K771272 09/12/1977 DISP. SYRINGES: 2,5 & L0 MI. BERMAN, PCP & CONSULTANTS, INC.
K771268 09/12/1977 INFUSION SET TYPE J BERMAN, PCP & CONSULTANTS, INC.
K771267 09/12/1977 INFUSION SET TYPE S BERMAN, PCP & CONSULTANTS, INC.
K771271 09/12/1977 SCALP VEIN SET BERMAN, PCP & CONSULTANTS, INC.
K771722 09/26/1977 SENSOMAT BIOCHEM INTERNATIONAL, INC.
K771591 09/20/1977 MINISTAT-S CHEMISTRY ANALYZER BIOKINETIX CORP.
K771414 09/22/1977 T4 BY RIA DIAG. KIT BIOMEDICAL LABS., INC.
K771241 09/15/1977 SPIR-E-VAC BREATHING SERVICES, INC.
K771583 09/02/1977 FLUORESCENT ANTI. ANTI-HUMAN C3 BURROUGHS WELLCOME CO.
K771560 09/15/1977 TOXHA TEST BURROUGHS WELLCOME CO.
K771775 09/30/1977 COLORPLAST TRANSVERSE SYSTEM C.R. BARD, INC.
K771750 09/30/1977 RF CHOKE CABLE C.R. BARD, INC.
K771658 09/12/1977 IDENTOFLEX CAVITRON CORP.
K771597 09/13/1977 IN VITRO FOLATE RADIOASSAY KIT CLINICAL ASSAYS, INC.
K771718 09/28/1977 CARDIOTHERM-500X COLUMBUS INSTRUMENTS INTL. CORP.
K771648 09/20/1977 COMPUTER ECG TERMINAL COMPUMED, INC.
K771416 09/12/1977 IRRIGATION/ASPIRATION NEEDLE CONCEPT, INC.
K771554 09/02/1977 SUTURE RETENTION CLAMP CONCEPT, INC.
K771732 09/28/1977 THORNTON ANTERIOR CHAMBER IRRIGATOR CONCEPT, INC.
K771673 09/30/1977 CATHETEO CARE TRAY #0242 CONCORD LABORATORIES, INC.
K771618 09/12/1977 COMPUTERIZED POSTURE PLATFORM CONTRAVES GOERZ CORP.
K770933 09/02/1977 BIO-SHIELD CSR WRAP CONVERTORS
K771324 09/02/1977 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID CORNING MEDICAL & SCIENTIFIC
K771566 09/14/1977 ENDOCAR. PACING LEAD-STD. LENGTH PL202 DAIG CORP.
K771565 09/14/1977 ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200 DAIG CORP.
K771564 09/14/1977 ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 DAIG CORP.
K771567 09/14/1977 ENDOCARD. PACING LEAD-LONG LENGTH PL203 DAIG CORP.
K771746 09/26/1977 FORCEPS DEPUY, INC.
K771744 09/28/1977 OSTEOTOMES FOR CUTTING BONH DEPUY, INC.
K771747 09/28/1977 PERIOSTEAL ELEVATOR DEPUY, INC.
K771745 09/28/1977 RASPS FOR SCRAPING BONE DEPUY, INC.
K771743 09/26/1977 SURG. SCISSORS FOR CUTTING TISSUE DEPUY, INC.
K771558 09/20/1977 SILASTIC BRAND OBSTETRICAL VACUUM CUP DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K770986 09/12/1977 FLEXI-THERM FILM E-Z-EM, INC.
K771682 09/20/1977 MIN-R CASSETTE EASTMAN KODAK COMPANY
K771681 09/14/1977 ORTHO H FILM EASTMAN KODAK COMPANY
K771691 09/22/1977 ANGLED FORCEP APPLIER EDWARD WECK, INC.
K771331 09/06/1977 CONDUCTIVE ELECTRODE GEL EDWARD WECK, INC.
K771751 09/28/1977 DISP. ELECTROSURGERY PENCIL EDWARD WECK, INC.
K771329 09/06/1977 DISP. GROUND PAD PREGELLED EDWARD WECK, INC.
K771330 09/06/1977 DISP. GROUND PLATE EDWARD WECK, INC.
K771752 09/28/1977 FINGER TIP CONTROL PENCIL EDWARD WECK, INC.
K771332 09/06/1977 PATIENT GROUNDING CABLES EDWARD WECK, INC.
K771663 09/20/1977 PROBE & CATHETER EDWARDS LABORATORIES
K771575 09/06/1977 ELECTRONIC EIPLATOR MODEL NO. 101 ELECTRONIC DEPILATORY, INC.
K771654 09/06/1977 NIMETICAP ESPE GMBH (US)
K771627 09/02/1977 PERMAGUM ESPE GMBH (US)
K771679 09/28/1977 MICROFLATOR FISONS CORP.
K771774 09/30/1977 NEW BASE FOR ORTHODONTIC APPLIANCES GAC INTL., INC. MARK MANNI
K771748 09/28/1977 INTRA ORAL X-RAY CONES GENERAL ELECTRIC CO.
K771514 09/12/1977 PREGNANCY TEST KIT GENERIC LABORATORY, LTD.
K771537 09/06/1977 AQUAMATIC K-MODULE MODEL K-20 GORMAN RUPP INDUSTRIES
K771661 09/12/1977 MIDDLEBROOK 7H11 AGAR (PLATE) GRANITE DIAGNOSTICS, INC.
K770956 09/12/1977 PAS ANTI-EMBOLISM SYSTEM HAMILTON INDUSTRIES, INC.
K771388 09/02/1977 AMYLASE ULTRAZYME PLUS HARLECO
K771389 09/02/1977 CK-1 ULTRAZYME PLUS HARLECO
K771623 09/20/1977 T3 RIA HOFFMANN-LA ROCHE, INC.
K771683 09/20/1977 AMPLIFIER MODEL N3B-EEG HONEYWELL, INC.
K771684 09/14/1977 AMPLIFIER MODEL N5A-ECG HONEYWELL, INC.
K771685 09/14/1977 AMPLIFIER MODEL N5A-HIS HONEYWELL, INC.
K771354 09/15/1977 PARALLEL PLATE DIALYZERS HOSPAL MEDICAL CORP.
K771587 09/02/1977 INSTANT AIR HYDE, VERNON E., D.D.S.
K771535 09/02/1977 LAS-R HUMAN CRP TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771664 09/12/1977 VOLUMETRIC INFUSION PUMP MODEL 960 IMED CORP.
K771466 09/02/1977 MULTISTAT III ALANINE AMINOTRANSFERASE INSTRUMENTATION LABORATORY CO.
K771475 09/13/1977 MULTISTAT III ALBUMIN TEST INSTRUMENTATION LABORATORY CO.
K771470 09/12/1977 MULTISTAT III ALKALINE PHOSPHATASE INSTRUMENTATION LABORATORY CO.
K771467 09/02/1977 MULTISTAT III ASPARTATE AMINOTRANSFERASE INSTRUMENTATION LABORATORY CO.
K771468 09/12/1977 MULTISTAT III CALCIUM TEST INSTRUMENTATION LABORATORY CO.
K771508 09/13/1977 MULTISTAT III CHOLESTEROL TEST INSTRUMENTATION LABORATORY CO.
K771464 09/02/1977 MULTISTAT III GLUCOSE TEST INSTRUMENTATION LABORATORY CO.
K771471 09/12/1977 MULTISTAT III GLUCOSE TEST INSTRUMENTATION LABORATORY CO.
K771465 09/02/1977 MULTISTAT III LACTIC DEHYDROGENASE INSTRUMENTATION LABORATORY CO.
K771469 09/12/1977 MULTISTAT III MAGNESIUM TEST INSTRUMENTATION LABORATORY CO.
K771477 09/12/1977 MULTISTAT III PHOSPHOROUS TEST INSTRUMENTATION LABORATORY CO.
K771476 09/12/1977 MULTISTAT III TOTAL PROTEIN TEST INSTRUMENTATION LABORATORY CO.
K771472 09/02/1977 MULTISTAT III TRIGLYCERIDE TEST INSTRUMENTATION LABORATORY CO.
K771509 09/13/1977 MULTISTAT III URIC ACID TEST INSTRUMENTATION LABORATORY CO.
K771474 09/13/1977 MULTISTAT III X-HBDH TEST INSTRUMENTATION LABORATORY CO.
K771473 09/13/1977 MULTISTAT III Y GT TEST INSTRUMENTATION LABORATORY CO.
K771622 09/13/1977 MULTISTAT III, AMYLASE TEST INSTRUMENTATION LABORATORY CO.
K771621 09/13/1977 MULTISTAT III, TOTAL BILIRUBIN TEST INSTRUMENTATION LABORATORY CO.
K771604 09/22/1977 SPECTROPHOTOMETEO IL MODEL 651 INSTRUMENTATION LABORATORY CO.
K771626 09/12/1977 PACEMAKER MODEL 251 INTERMEDICS, INC.
K771258 09/06/1977 BLOOD CELL SEPARATOR 2997 INTL. BUSINESS MACHINES
K771624 09/06/1977 COPE LUNG FORCEPS #305-218 J. JAMNER SURGICAL INSTRUMENTS, INC.
K771625 09/12/1977 LEININGEO AORTIC PUNCH #310-395 & 397 J. JAMNER SURGICAL INSTRUMENTS, INC.
K771716 09/20/1977 CYMET-PLUS J.T. BAKER CHEMICAL CO.
K771147 09/15/1977 AVL BLOOD GAS INSTRUMENT MODEL 939 JONES MEDICAL INSTRUMENT CO.
K771563 09/12/1977 CONFORM ELASTIC NETTING KENDALL RESEARCH CENTER
K771452 09/12/1977 CONFORM STRETCH BANDAGE (5SIZES) KENDALL RESEARCH CENTER
K771079 09/15/1977 CURITY IRRIGATION TRAY KENDALL RESEARCH CENTER
K771411 09/23/1977 ESOPHAGEAL STETH. TEMP. SENSOR LABARGE, INC.
K771520 09/23/1977 ESOPHAGEAL STETHOSCOPE LABARGE, INC.
K771650 09/20/1977 AKRO-SIL FOLEY KIT 30CC LATEX IND., INC.
K771651 09/20/1977 AKRO-SIL FOLEY KIT 5CC LATEX IND., INC.
K771652 09/20/1977 CATH-CARE TRAY LATEX IND., INC.
K771719 09/20/1977 KARAYA ELECTRODES LECTEC CORP.
K770993 09/02/1977 TRIGLYCERIDE REAGENT SET MACOMB CHEMICAL CO.
K771550 09/20/1977 MRT DISPENSOR MCGAW RESPIRATORY THERAPY
K771765 09/30/1977 MYO-CHECK MED GENERAL
K771377 09/02/1977 THYRODOT-4, THYRODOT-SH MEDCOM DIAGNOSTICS, INC.
K771435 09/20/1977 URINARY LEG BAG, STEOILE MEDDEV INTERNATIONAL CORP.
K771573 09/15/1977 DUO-CATH FEMORAL MEDICAL DEVICE LABORATORIES
K771636 09/30/1977 BODY RESTRAINT MEDICAL RESTRAINTS, INC.
K771632 09/28/1977 FINGER MITT RESTRAINT MEDICAL RESTRAINTS, INC.
K771676 09/20/1977 FOOT DROP BOOT MEDICAL RESTRAINTS, INC.
K771635 09/28/1977 FOOT ELEVATOR MEDICAL RESTRAINTS, INC.
K771629 09/30/1977 HAND RESTRAINT MEDICAL RESTRAINTS, INC.
K771633 09/12/1977 HEEL PROTECTOR MEDICAL RESTRAINTS, INC.
K771630 09/30/1977 LIMB RESTRAINT MEDICAL RESTRAINTS, INC.
K771715 09/28/1977 PELVIC WHEELCHAIR RESTRAINT MEDICAL RESTRAINTS, INC.
K771634 09/28/1977 VEST RESTRAINT MEDICAL RESTRAINTS, INC.
K771631 09/12/1977 WHEELCHAIR SAFETY BELT MEDICAL RESTRAINTS, INC.
K771606 09/15/1977 IMMUNOSPOT NEONATAL T4 TEST MELOY LABORATORIES, INC.
K771382 09/02/1977 IMMUNOSTAT T3 UPTAKE TEST MELOY LABORATORIES, INC.
K771004 09/12/1977 AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI MILES LABORATORIES, INC.
K771665 09/12/1977 OXYGEN CONCENTRATOR MTC
K771659 09/30/1977 PATIENT RESTRAINT SYSTEM MTD, INC.
K771749 09/28/1977 AMALGAM DISPENSER NEW DIMENSIONS IN MEDICINE, INC.
K771590 09/15/1977 THYROID STIMULATING HORMONE NEW ENGLAND NUCLEAR
K771449 09/06/1977 ARTEOIAL TONOMETER ML-105 NICOLET BIOMEDICAL INSTRUMENTS
K771706 09/20/1977 SAIF-BOW NORTHWEST ORTHODONTICS, INC.
K771643 09/28/1977 NOVA 2 IONIZED CALCIUM ANALYZER NOVA BIOMEDICAL CORP.
K771438 09/02/1977 AUTONORM NYEGAARD & CO. A/S
K771439 09/02/1977 PATHONORM H & L NYEGAARD & CO. A/S
K771436 09/02/1977 SERONORM NYEGAARD & CO. A/S
K771437 09/02/1977 SERONORM LIPID NYEGAARD & CO. A/S
K770603 09/02/1977 HYPRONOSTICON TM ORGANON, INC.
K771410 09/02/1977 RHEUMANOSTICON R ORGANON, INC.
K771642 09/14/1977 ADAPTER A-413 PACESETTER SYSTEMS
K771641 09/14/1977 UNIVERSAL LEAD ADAPTER, UA-414 PACESETTER SYSTEMS
K771605 09/15/1977 CREATINE KINASE ISOENZYME SUBSTRATE SET PFIZER PHARMACEUTICALS
K771620 09/15/1977 ALKALINE PHOSPHATASE ISOENZY. SUB. SET PFIZER, INC.
K771578 09/02/1977 PHADEBAS RAST PENICLLOYL G/V TEST PHARMACIA, INC.
K771760 09/28/1977 EXTEMP PHARMACO, INC.
K771759 09/28/1977 EXTEMP-V PHARMACO, INC.
K771739 09/30/1977 PENTAX LH-150F LIGHT SOURCE PILLING CO.
K771448 09/06/1977 STERILE SUTURE REMOVAL KIT PREMIUM PLASTICS, INC.
K771697 09/20/1977 CARDIO-EXERCISE TREADMILL 550 QUINTON, INC.
K771611 09/06/1977 PROTECTOR RICHARD-ALLAN MEDICAL IND., INC.
K771580 09/02/1977 TEKTALLY II SCIENTIFIC PRODUCTS
K771666 09/30/1977 SPHYGMOMANOMETER #1235 SEARS, ROEBUCK & CO.
K771116 09/15/1977 CATHETER, PO2, INTRAVASUCLAR, CITADEL SHERWOOD MEDICAL INDUSTRIES
K771244 09/12/1977 2,2DIMETHOXY-2-PHENYLACETOPHENONE SOLAR LABORATORIES, INC.
K771688 09/26/1977 ECHO-OCULOMETER STORZ INSTRUMENT CO.
K771418 09/22/1977 PIN RETRACTORS STRYKER CORP.
K771531 09/06/1977 LAPAROTOMY SPONGES SURGILITE INTL., INC.
K771670 09/12/1977 IMPLANTED PACEMAKER PLUSE GENERATOR TELECTRONICS, INC.
K771431 09/28/1977 ARTIFICIAL K-NOSE BREATHAID TERUMO AMERICA, INC.
K771430 09/20/1977 BLOOD FILTER, W/SET TERUMO AMERICA, INC.
K771693 09/20/1977 CLIRANS BLOOD LINES SET TERUMO AMERICA, INC.
K771694 09/15/1977 CLIRANS TH 15 HOLLOW FIBER DIALYZER TERUMO AMERICA, INC.
K771432 09/28/1977 HICALIQ IVH BAG TERUMO AMERICA, INC.
K771212 09/12/1977 SAFEED DISP. PLASTIC CATHETER TERUMO AMERICA, INC.
K771617 09/02/1977 SPECI-MIX THERMOLYNE CORP.
K771707 09/26/1977 ADIDYNE 3000 TIMETER INSTRUMENT CORP.
K771599 09/20/1977 GAMMA CAMERAS -GXA-301 & GCA-402 TOSHIBA MEDICAL SYSTEMS
K771600 09/22/1977 ULTRASOUND TOSHIBA MEDICAL SYSTEMS
K771601 09/20/1977 X-RAY REMOTE CONTROL TABLE TOSHIBA MEDICAL SYSTEMS
K771584 09/13/1977 ARTEOIAL BLOOD SAMPLING KIT 2D9014 TRAVENOL LABORATORIES, S.A.
K771375 09/15/1977 PRESSURE MODULE 5M1247 TRAVENOL LABORATORIES, S.A.
K771112 09/30/1977 AUTO SUTURE R CLIP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771113 09/30/1977 AUTO SUTURE R CLIP INSTRUMENT UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771640 09/30/1977 SUTURE CLIP REMOVER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771515 09/30/1977 SUTURE TISSUE APPROXIMATING FORCEP UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771306 09/14/1977 THERMOCATH VICTORY ENGINEERING CORP.
K771561 09/07/1977 DOVER URINE METER WILL ROSS CO.
K771725 09/26/1977 BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. XOMED, INC.
K771727 09/26/1977 BIOSPONGE RECONSTRUCTION DISCS XOMED, INC.
K771726 09/26/1977 BIOSPONGE STAPES PISTON XOMED, INC.


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