FDA 510(k) Applications Received During August, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K760507 08/23/1976 FORCEP, THUMB ACME UNITED CORP.
K760368 08/04/1976 MONITORING & STRESS TESTING EQUIPMENT ADVANCED MEDICAL, INC.
K760361 08/02/1976 BLADE, SURGICAL SCALPEL, STERILE AEROCEUTICALS
K760364 08/02/1976 HANDLE, SCALPEL, STAINLESS STEEL AEROCEUTICALS
K760362 08/02/1976 LANCET, BLOOD, STERILE STAINLESS STEEL AEROCEUTICALS
K760363 08/02/1976 SCALPEL, SURGICAL, STERILE STAINLESS AEROCEUTICALS
K760442 08/16/1976 NEBULIZER ADAPTER (AERMIST) AERWAY LABORATORIES, INC.
K760440 08/16/1976 CATHETER, NATURAL LATEX URETHRAL AKRON CATHETER, INC.
K760748 08/27/1976 REAGENTS FOR BLOOD GAS INSTRUMENTATION ALKO SCIENTIFIC CO.
K760451 08/16/1976 AIR WATER SOURCE (ACMI MODEL 710) AMERICAN CYSTOCOPE MAKERS, INC.
K760452 08/16/1976 COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) AMERICAN CYSTOCOPE MAKERS, INC.
K760373 08/05/1976 RADIOASSAY KIT, IM.72 FSH AMERSHAM CORP.
K760358 08/02/1976 ELECTRODE SERIES 1600 ANDOVER MEDICAL, INC.
K760421 08/10/1976 THERMOMETER, SURVALENT-ELECTRONIC ARBROOK MFG. CORP.
K760498 08/23/1976 TRAY, DISPOSABLE ARGON MEDICAL CORP.
K760512 08/24/1976 TOOTHBRUSH ASSET SCIENTIFIC & PHARMACEUTICAL, INC.
K760381 08/05/1976 BLOOD TRANSFUSION SET (SANGOFIX) B. BRAUN INSTRUMENTS
K760389 08/05/1976 CANNULA, IV B. BRAUN INSTRUMENTS
K760387 08/05/1976 CATHETER, CAVA (CAVAFIX) B. BRAUN INSTRUMENTS
K760390 08/05/1976 CATHETER, VEIN (BRAUNULA T) B. BRAUN INSTRUMENTS
K760391 08/05/1976 CATHETER, VEIN (BRAUNULA) B. BRAUN INSTRUMENTS
K760388 08/05/1976 CATHETER, VEIN (VENOFIX) B. BRAUN INSTRUMENTS
K760386 08/05/1976 CENTRAL VEINOUS PRESSURE SETS B. BRAUN INSTRUMENTS
K760382 08/05/1976 CONNECTORS B. BRAUN INSTRUMENTS
K760385 08/05/1976 EXTENSION SETS B. BRAUN INSTRUMENTS
K760380 08/05/1976 INTRAVENOUS TRANSFER SET (INTRAFIX) B. BRAUN INSTRUMENTS
K760383 08/05/1976 STOPCOCKS B. BRAUN INSTRUMENTS
K760384 08/05/1976 STOPPERS B. BRAUN INSTRUMENTS
K760392 08/05/1976 SYRINGES B. BRAUN INSTRUMENTS
K760458 08/17/1976 BOTTLE, BLOOD CULTURE, SCHAEDLER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760459 08/17/1976 MUELLER HINTON AGAR W/HEMOGLOBIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760460 08/17/1976 SCHAEDLER SELECTIVE AGAR-KV BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760457 08/17/1976 SCHAEDLER-SELECTIVE AGAR CNA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760415 08/09/1976 ENZYMATIC AMYLASE REAGENT KIT BECKMAN INSTRUMENTS, INC.
K760414 08/09/1976 ENZYMATIC BUN REAGENT KIT BECKMAN INSTRUMENTS, INC.
K760424 08/12/1976 LIQUID SCINTILLATION COUNTER BECKMAN INSTRUMENTS, INC.
K760546 08/30/1976 REAGENT KIT, ENZYMATIC CO2 BECKMAN INSTRUMENTS, INC.
K760393 08/06/1976 BED PAN, STACKABLE (AUTOCLAVABLE) BEMIS HEALTH CARE
K760453 08/16/1976 REGULATOR, PRESSURE, CUFF BOEHRINGER LABORATORIES
K760430 08/13/1976 BUN-REATIVE BOEHRINGER MANNHEIM CORP.
K760445 08/16/1976 DENTAL PROPHYLAXIS UNIT ULTRASONIC BRANSON ULTRASONICS CORP.
K760506 08/23/1976 HEMAFLOUR ZP BUCHLER INSTRUMENTS, INC.
K760394 08/06/1976 REAGENT, CHLORIDOMETER ACID BULCHER INSTRUMENTS
K760455 08/16/1976 OBSTETRICAL PACK (VIGILON OB PACK) C.R. BARD, INC.
K760366 08/04/1976 REAGENT, Y-GT MAX-PACK CALBIOCHEM
K760422 08/10/1976 SURGICAL RETRACTOR CUTTER LABORATORIES, INC.
K760416 08/09/1976 DATA-TOPE SYSTEM DIGOXIN RIA DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760549 08/30/1976 PLATELET CONTROLS, NORMAL & ABNORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760471 08/19/1976 LAMP, FLOURESCENT BLACK, HIGH OUTPUT DERMATRON CORP.
K760482 08/19/1976 SUNLAMP (F40-UVB & F20-UVB) DERMATRON CORP.
K760519 08/26/1976 SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 DERMATRON CORP.
K760420 08/06/1976 FILTER, VACUUM LINE LINEGUARD DIEMOLDING CORP.
K760371 08/05/1976 VENT-O2-CATH DRYDEN CORP.
K760462 08/18/1976 ELECTRICAL SHOCK DEVICE EDWARD V. KAUFHOLZ, SR.
K760423 08/11/1976 ELECTROLYSIS MACHINE (PERMATRON) EPCO HAIR REMOVAL CORP.
K760374 08/05/1976 DIALYZER (MODEL 1850) ERIKA, INC.
K760543 08/30/1976 BROMCRESOL GREEN FISHER SCIENTIFIC CO., LLC.
K760527 08/27/1976 T-PAD GAYMAR INDUSTRIES, INC.
K760545 08/30/1976 WEIGHING STATION, MOBILE PATIENT GAYMAR INDUSTRIES, INC.
K760466 08/18/1976 TABLE, X-RAY, RFX CLASSICAL GENERAL ELECTRIC CO.
K760485 08/20/1976 HEMASTAIN FIXATIVE GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760487 08/20/1976 HEMASTAIN PHOSPHATE BUFFER GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760486 08/20/1976 HEMASTAIN WRIGHT STAIN GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760356 08/02/1976 DISH, STERILE DISPOSABLE POLYSTYRENE GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K760533 08/30/1976 CATHETER, FLOW DIRECTED THERMAL DILUTION GOULD, INC.
K760532 08/30/1976 COMPUTER, CARDIAC OUTPUT (#SP1425) GOULD, INC.
K760484 08/20/1976 STAIN SET, HISTOCHEMICAL AFB HARLECO
K760542 08/30/1976 ELECTROCARDIOGRAPH (#1505A) HEWLETT-PACKARD CO.
K760523 08/26/1976 MONITOR SCOPE HEWLETT-PACKARD CO.
K760464 08/18/1976 PHON/STRESS SYSTEM (#21126A) HEWLETT-PACKARD CO.
K760539 08/30/1976 RECORDER (#78640A) HEWLETT-PACKARD CO.
K760465 08/18/1976 STRESS SYSTEM, 3-CHANNEL (#21127A) HEWLETT-PACKARD CO.
K760463 08/18/1976 STRESS SYSTEM, SINGLE-CHANNEL (#21125) HEWLETT-PACKARD CO.
K760501 08/23/1976 VALVE, STANDARD MODEL PUDENZE FLUSHING HEYER SCHULTE CORP.
K760372 08/05/1976 HUMIDIFIER, DISPOSABLE HOSPITEK
K760454 08/16/1976 GOUFFON PIN, ADJUSTABLE HOWMEDICA CORP.
K760488 08/20/1976 AIRWAY, DUAL CHANNEL HUDSON OXYGEN THERAPY SALES CO.
K760489 08/20/1976 NEBULIZER, HANDHELD (T "UP-DRAFT) HUDSON OXYGEN THERAPY SALES CO.
K760468 08/18/1976 TEST, REFORMULATED HYCEL HMA CALCIUM HYCEL, INC.
K760499 08/23/1976 REAGENT, PARTIAL THROMBOPLASTIN HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760354 08/02/1976 TEST, SLIDE FOR C-REATIVE PROTEIN ICL SCIENTIFIC
K760461 08/18/1976 NOSE CLIP INSPIRON CORP.
K760448 08/16/1976 SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT INSTRUMENTATION LABORATORY CO.
K760425 08/12/1976 TAMPON, PLAYTEX 2 VERSION A INTL. PLAYTEX, INC.
K760426 08/12/1976 TAMPON, PLAYTEX 2 VERSION B INTL. PLAYTEX, INC.
K760410 08/09/1976 AMP BUFFER J.T. BAKER CHEMICAL CO.
K760406 08/09/1976 CAFFEINE DILUENT J.T. BAKER CHEMICAL CO.
K760401 08/06/1976 COCAINE KIT, TOXI-PAK J.T. BAKER CHEMICAL CO.
K760412 08/09/1976 LDH SUBSTRATE J.T. BAKER CHEMICAL CO.
K760411 08/09/1976 NAD (SPOONPAK CONTAINER) J.T. BAKER CHEMICAL CO.
K760408 08/09/1976 POTASSIUM SODIUM TARTRATE J.T. BAKER CHEMICAL CO.
K760397 08/06/1976 REAGENT, AMP BUFFER DIAGNOSTIC J.T. BAKER CHEMICAL CO.
K760398 08/06/1976 REAGENT, MAGNESIUM CHLORIDE J.T. BAKER CHEMICAL CO.
K760399 08/06/1976 REAGENT, P-NITROPHENYL PHOSPHATE J.T. BAKER CHEMICAL CO.
K760409 08/09/1976 SODIUM NITRITE J.T. BAKER CHEMICAL CO.
K760407 08/09/1976 SULFANILIC ACID J.T. BAKER CHEMICAL CO.
K760502 08/23/1976 VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH. JOE W. UTT
K760396 08/06/1976 TEST, MACROGLOBULIN KIT (ALPHA2) KALLESTAD LABORATORIES, INC.
K760428 08/13/1976 SUTURE RACK & NEEDLE COUNTER KLEEN TEST PRODUCTS
K760400 08/06/1976 BONDING AGENT, VYTOL L.D. CAULK CO.
K760378 08/05/1976 CEMENT, RESIN DENTAL (AUTO-TACH) L.D. CAULK CO.
K760376 08/05/1976 CEMENT, RESIN DENTAL (SOLO-TACH) L.D. CAULK CO.
K760379 08/05/1976 DENTAL AMALGAM ALLOY (SPHERICAL II) L.D. CAULK CO.
K760377 08/05/1976 FILLING, RESIN DENTAL (VYTOL) L.D. CAULK CO.
K760405 08/09/1976 SEALANT, NEW FILLED L.D. CAULK CO.
K760518 08/26/1976 ADAPTER, PER-CEN-TOX-BODY LANDMARK PLASTICS
K760492 08/23/1976 BASIN, LARGE OR SMALL LANDMARK PLASTICS
K760495 08/23/1976 BASIN, RECTANGULAR WASH LANDMARK PLASTICS
K760494 08/23/1976 BASIN, ROUND WASH LANDMARK PLASTICS
K760490 08/23/1976 BEDPAN, GENERAL MEDICAL MEDI-PAK LANDMARK PLASTICS
K760551 08/30/1976 CANNULA, LARRIAT LANDMARK PLASTICS
K760548 08/30/1976 CARAFE AND LINER LANDMARK PLASTICS
K760517 08/25/1976 CUP, DISPOSABLE MEDICINE LANDMARK PLASTICS
K760496 08/23/1976 CUP, DISPOSABLE SPECIMEN LANDMARK PLASTICS
K760493 08/23/1976 DISH, SOAP LANDMARK PLASTICS
K760552 08/30/1976 THERMOMETER STAND AND DUST COVER LANDMARK PLASTICS
K760497 08/23/1976 TRAY, SERVICE LANDMARK PLASTICS
K760491 08/23/1976 TUMBLER, GENERAL MEDICAL MEDI-PAK LANDMARK PLASTICS
K760467 08/18/1976 ROTATOR, FIXED SPEED LEDERLE LABORATORIES
K760418 08/09/1976 9075 LEE PHARMACEUTICALS
K760419 08/09/1976 ADHESION PROMOTOR LEE PHARMACEUTICALS
K760417 08/09/1976 LEE-FILL ULTRAVIOLET-CURED REST. MAT. LEE PHARMACEUTICALS
K760470 08/19/1976 COUNTER, RACK GAMMA (#1270) LKB INSTRUMENTS, INC.
K760395 08/06/1976 PHOTOMETER, SEROMETER (MODEL 380) MALLINCKRODT CRITICAL CARE
K760355 08/02/1976 TEST, SEROSONIC ALBUMIN MALLINCKRODT CRITICAL CARE
K760522 08/26/1976 TABLE, UROSURGICAL MALLINCKRODT GROUP, INC.
K760504 08/23/1976 PLETHYSMOGRAPH (MDI SYSTEM II) MARKETING DEVELOPMENT INTL.
K760520 08/26/1976 CALIPERS, MCGAW SKINFOLD MCGAW LABORATORIES
K760521 08/26/1976 TAPE MEASURE MCGAW LABORATORIES
K760443 08/16/1976 CARDIAC ELECTRODE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760516 08/25/1976 FELT, SURGICAL DACRON MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760508 08/24/1976 ACCUTAPE 24 MEDCRAFT CORP.
K760510 08/24/1976 MONITORING SYSTEM, REHABILITATION MEDCRAFT CORP.
K760509 08/24/1976 TREADMILL, DIAGNOSTIC MEDCRAFT CORP.
K760550 08/30/1976 IMPLANT, SILICONE AND TANTALUM MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
K760481 08/17/1976 FILTER, PARTICULATE ARRESTING MILES LABORATORIES, INC.
K760472 08/19/1976 INSTRUMENTED SYSTEM FOR URINALYSIS MILES LABORATORIES, INC.
K760352 08/02/1976 CIRCUIT, INTENSIVE CARE VENTILATOR MONAGHAN MEDICAL CORP.
K760359 08/02/1976 ELECTRODE, BOVIE DISPERSIVE NIXON, HARGRAVE, DEVANS
K760402 08/06/1976 SYRINGE SET, 3-WAY THERMODILUTIN OMP LABORATORIES, INC.
K760404 08/09/1976 BI-CENTRIC SYSTEM PELTON & CRANE CO.
K760469 08/19/1976 CLEANSING AGENT, NEW WOUND (DEBRISSU) PHARMASEAL LABORATORIES
K760353 08/02/1976 CRYOLYZER ALPHA PILLING CO.
K760360 08/02/1976 SHIRT, MITTEN CUFF INFANT PRECEPT, INC.
K760346 08/02/1976 ASSAY FOR GAMMA GLUTAMYLTRANSFERASE PRINCETON BIOMEDIX
K760347 08/02/1976 SET, TRINDER GLUCOSE PRINCETON BIOMEDIX
K760345 08/02/1976 TEST, LACTATE DEHYDROGENASE PRINCETON BIOMEDIX
K760547 08/30/1976 STIMULATOR, ELECTRICAL MUSCLE (#MD-4) R. A. FISCHER CO. CORP.
K760503 08/23/1976 STIMULATOR, ELECTRICAL MUSCLE (#MD-8) R. A. FISCHER CO. CORP.
K760437 08/16/1976 CAUSSE MODIFIED TEFLON PISTON, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760435 08/16/1976 PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT RICHARD'S MEDICAL EQUIP., INC.
K760439 08/16/1976 PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760433 08/16/1976 SHEA TORP, OTOLOGY IMPLANT RICHARD'S MEDICAL EQUIP., INC.
K760438 08/16/1976 SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760434 08/16/1976 TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760524 08/26/1976 CATHETER CONNECTOR, ARGYLE TUBING SHERWOOD MEDICAL INDUSTRIES
K760351 08/02/1976 CATHETER, ARGYLE THORACIC SHERWOOD MEDICAL INDUSTRIES
K760350 08/02/1976 MONITOR, CITADEL INTRAVASCULAR PO2 SHERWOOD MEDICAL INDUSTRIES
K760349 08/02/1976 BILIRUBIN REF., SIGMA STOCK NO. 605-10 SIGMA CHEMICAL CO.
K760449 08/16/1976 LIPID CONTROL SIGMA CHEMICAL CO.
K760348 08/02/1976 REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 SIGMA CHEMICAL CO.
K760473 08/17/1976 REAGENT, ALBUMIN DETERMINATION SIMMLER & SON, INC.
K760474 08/17/1976 REAGENT, ALKALINE PHOSPHATASE DETERM. SIMMLER & SON, INC.
K760478 08/17/1976 REAGENT, BUN (UREA NITROGEN) DETERM. SIMMLER & SON, INC.
K760475 08/17/1976 REAGENT, CALCIUM DETERMINATION SIMMLER & SON, INC.
K760476 08/17/1976 REAGENT, LACTATE DEHYDROGENASE SIMMLER & SON, INC.
K760479 08/17/1976 REAGENT, TOTAL BILIRUBIN DETERMINATION SIMMLER & SON, INC.
K760480 08/17/1976 REAGENT, TOTAL PROTEIN DETERMINATION SIMMLER & SON, INC.
K760477 08/17/1976 REAGENTS-4 FOR URIC ACID DETERMINATION SIMMLER & SON, INC.
K760413 08/09/1976 TAPE, LIGHTCAST II WB SOLAR LABORATORIES, INC.
K760456 08/17/1976 TABLE, HAND SURGI STRYKER CORP.
K760554 08/31/1976 APPAREL, BARRIER SCRUB SURGIKOS, INC.
K760369 08/04/1976 POWDERLITE THE S. S. WHITE CO.
K760483 08/20/1976 BLOOD-SOLUTION ADMINISTRATION SET, SURG. TRAVENOL LABORATORIES, S.A.
K760544 08/30/1976 CATHETER, PERITONEAL DIALYSIS TRAVENOL LABORATORIES, S.A.
K760505 08/23/1976 SOLUTION ADMINISTRATION SET (#2C0631) TRAVENOL LABORATORIES, S.A.
K760553 08/30/1976 PRINTER TURNER ASSOC.
K760500 08/23/1976 TUBE, HEAVY GLASS WALL INJECTION UNIMETRICS CORP.
K760403 08/09/1976 TEMPORARY ATRIAL ELECTRODE KIT USCI, DIV. C.R. BARD, INC.
K760357 08/02/1976 SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI) V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760370 08/05/1976 INFUSION EQUIPMENT, INTRAVENOUS VALLEYLAB, INC.
K760429 08/13/1976 FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS. VARIAN ASSOC., INC.
K760444 08/16/1976 PHOTOCOAGULATOR, LOG 3 PORTABLE XENON VARIAN ASSOC., INC.
K760427 08/13/1976 CATHETER, DOVER SUCTION W/ GLOVE WILL ROSS CO.
K760515 08/25/1976 DISC THINNER, WILL-CERUM LIQUID WILLIAMS GOLD REFINING CO., INC.
K760514 08/25/1976 DISC, WILL-CERUM LIQUID WILLIAMS GOLD REFINING CO., INC.
K760365 08/03/1976 BLANKET, BURN WINN HIRSCH & ASSOC.
K760513 08/25/1976 ELECTRODE, TEMPORARY MYOCARDIAL WINN HIRSCH & ASSOC.
K760441 08/16/1976 BODY WARMER (SHAKE-N-WARM) YAMADA CO., LTD OF JAPAN


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