FDA 510(k) Applications Received During August, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K781504 08/30/1978 125I-ALDOSTERONE RIA DIAG. KIT ABBOTT LABORATORIES
K781423 08/17/1978 DUAL COMPONENT STANDARDS ABBOTT LABORATORIES
K781406 08/14/1978 HYDRON BURN BANDAGE MANUAL APPLICATION ABBOTT LABORATORIES
K781370 08/08/1978 MS-2 AUTOMATED URINE SCREENING SYSTEM ABBOTT LABORATORIES
K781427 08/22/1978 MS-2 BACTERIAL ID. SYSTEM ABBOTT LABORATORIES
K781354 08/08/1978 PILLOWS- SINGLE PATIENT USE ABCO DEALERS, INC.
K781343 08/04/1978 RESURFACE PROSHESIS AESCULAP INSTRUMENTS CORP.
K781376 08/09/1978 STANDARDIZE TGCL & TGCH AMERICAN MONITOR CORP.
K781456 08/23/1978 ENDOCARDIAL BIPOLAR LEAD AMERICAN TECHNOLOGY, INC.
K781326 08/01/1978 UNIPOPLAR ENDOCARDIAL LEADS AMERICAN TECHNOLOGY, INC.
K781410 08/14/1978 RIALYZE VITAMIN B-12 TEST AMES DIV., MILES LABORATORIES, INC.
K781441 08/21/1978 BCG ALBUMIN REAGET ANALYTICAL & RESEARCH CHEMICALS, INC.
K781460 08/21/1978 CHLORIDE REAGENT ANALYTICAL & RESEARCH CHEMICALS, INC.
K781333 08/02/1978 CENTRAL CATHETER TRAY ARGON MEDICAL CORP.
K781469 08/28/1978 POSITIVE PLACEMENT ANETHESIA KIT ARROW INTL., INC.
K781429 08/21/1978 HAND-TROL CONNECTOR EXTENDER ASPEN LABORATORIES, INC.
K781364 08/07/1978 PINT BOTTLE WELL BAXA CORP., SUB. OF COOK GROUP, INC.
K781331 08/02/1978 A-V FISTULA NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781330 08/02/1978 BLOOD LEVEL DETECTOR-MODEL 7601 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781337 08/03/1978 CONJUGATED BILE ACIDS RIA KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781436 08/18/1978 DELTA TEST ASSAY, HDL CHLORESTEROL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781501 08/30/1978 ENZAC INCUBATOR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781442 08/23/1978 BECKMAN ASTRA SYSTEM BECKMAN INSTRUMENTS, INC.
K781355 08/07/1978 ICS NORMAL CONTROL SERUM BECKMAN INSTRUMENTS, INC.
K781472 08/28/1978 MITROPHENYL, ALKALINE PHOSPHATES BECKMAN INSTRUMENTS, INC.
K781432 08/21/1978 STAT ULTRA VIOLET LIQUID BECKMAN INSTRUMENTS, INC.
K781387 08/10/1978 INSTA-PULSE HEART RATE MONITOR BIO SIG INSTRUMENTS, INC.
K781397 08/11/1978 EM-V BIOLOGICAL CORP. OF AMERICA
K781389 08/10/1978 BIOMET CONCENTRIC HEX SCREW BIOMET, INC.
K781385 08/11/1978 DOBBHOFF ENTERIC FEEDING BAG BIOSEARCH MEDICAL PRODUCTS, INC.
K781428 08/21/1978 FLEXTUBES:9", 20", 26" BOURNS MEDICAL SYSTEMS, INC.
K781515 08/31/1978 MODEL LS-80 ADULT VENTILATION MONITOR BOURNS MEDICAL SYSTEMS, INC.
K781485 08/28/1978 PATIENT CIRCUIT MANIFOLD BOURNS MEDICAL SYSTEMS, INC.
K781347 08/07/1978 CAMCO QUIK STAIN II CAMBRIDGE CHEMICAL PRODUCTS, INC.
K781353 08/07/1978 PAPILLOTOME CUTTING SNARE CAMERON-MILLER, INC.
K781484 08/28/1978 CASTLE MODEL 3146 GAS AERATOR CASTLE CO.
K781462 08/25/1978 AUTO-FIELD II OPHTHALMIC FIELD SCANNER CAVITRON CORP.
K781421 08/17/1978 BIOSCAN E12 CLINIFAX INDUSTRIES, LTD.
K781369 08/08/1978 MICRODILUTION ANAEROBE ID. PANEL CNR LABS
K781368 08/08/1978 MICRODILUTION GRAM-NEGATIVE ID. PANEL CNR LABS
K781367 08/08/1978 MICRODILUTION STREP ID. PANEL CNR LABS
K781452 08/23/1978 BAYLOW VISUAL ACUITY TESTER CODMAN & SHURTLEFF, INC.
K781411 08/15/1978 CORNEAL CUTTER AND ACCESSORIES CODMAN & SHURTLEFF, INC.
K781465 08/25/1978 MICROSURGICAL KNIVES, 20, 30, 45 CODMAN & SHURTLEFF, INC.
K781412 08/15/1978 OSCILLATING KNIFE AND ACCESSORIES CODMAN & SHURTLEFF, INC.
K781393 08/10/1978 VARIABLE STIFFNESS WIRE GUIDE COOK, INC.
K781377 08/09/1978 OVALITH 10BP CORATOMIC, INC.
K781409 08/14/1978 IMMO PHASE, THYROID HORMONE CORNING MEDICAL & SCIENTIFIC
K781486 08/28/1978 STERI-VAC POWER UNITS CPAC, INC.
K781363 08/07/1978 CAST SHOE CUTLER BIOMEDICAL
K781140 08/21/1978 CUTTER RESIFLEX FOLEY CATHETERS CUTLER LABORATORIES, INC.
K781407 08/14/1978 ERM-101 CYNERGY
K781381 08/11/1978 EMIT METHATREXATE ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K781480 08/28/1978 ANTITHROMBIN III ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781479 08/28/1978 HEPARIN ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781478 08/28/1978 PLASMINOGEN ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781345 08/07/1978 ULTRAFILL- ULTRABOUND DEMETRON RESEARCH CORP.
K781488 08/28/1978 MVS-MODEL SEU-6, DEU-6 DENTSPLY INTL.
K781338 08/04/1978 BEAVER CATARACT CYROXTRACTOR EDWARD WECK, INC.
K781455 08/23/1978 SIEMENS ULTRATHERM 708 ELMED, INC.
K781386 08/11/1978 EBS 775 TONOMETER EQUILIBRATED BIO SYSTEMS, INC.
K781380 08/11/1978 MARNE M.T.P.J. ORTHOPEDIC IMPLANT FARAH LTD.
K781371 08/08/1978 BONE MARROW ASPIRATION KIT FERRIS MFG. CORP.
K781466 08/24/1978 AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT FISHER SCIENTIFIC CO., LLC.
K781388 08/10/1978 F.A. MOUNTING MEDIUM FLOW LABORATORIES, INC.
K781390 08/10/1978 MYCOPLASMA HYORHINIS (BTS-7) FLOW LABORATORIES, INC.
K781391 08/10/1978 PBS FOR FA (46-991-49) FLOW LABORATORIES, INC.
K781344 08/04/1978 OPTION PHO/SONIC B-MODE SCANNER G.D. SEARLE AND CO.
K781431 08/21/1978 ELECTRIC CT/T OPERATOR DISPLAY CONSOLE GENERAL ELECTRIC CO.
K781372 08/09/1978 LIQUID T.B.C. MEDIUM GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K781404 08/10/1978 BED PADS: D-12 AND D-8 GRANT AIRMASS CORP.
K781493 08/28/1978 EEG GEL GRAPHIC CONTROLS CORP.
K781494 08/28/1978 EEG LEAD ASSEMBLY GRAPHIC CONTROLS CORP.
K781471 08/28/1978 PNEUMATIC VITRECTOMY CONTROL UNIT HELFGOTT MEDICAL INSTRUMENTS
K781359 08/07/1978 MODEL 80032A, OBSTETRICAL TELEMETRY HEWLETT-PACKARD CO.
K781360 08/07/1978 MODEL 80100A, PATIENT DATA MEMORY HEWLETT-PACKARD CO.
K781373 08/07/1978 OSTOMY APPLIANCE W/DEODORIZING FILTER HOLLISTER, INC.
K781464 08/25/1978 HEMODIALYZER, MODEL RP610, RP AN 69 HOSPAL MEDICAL CORP.
K781408 08/14/1978 RID SYSTEM-(ACP) TEST ICL SCIENTIFIC
K781395 08/14/1978 DISPOSABLE AEROSOL "T" BRIGGS ADAPTOR INHAL-O-TECH MEDICAL PLASTIC
K781394 08/14/1978 DISPOSABLE INCENTIVE SPIROMETER INHAL-O-TECH MEDICAL PLASTIC
K781361 08/07/1978 HEMOGLOBINOMETER MODEL 720 B INNOVATIVE MEDICAL SYSTEMS, INC.
K781349 08/07/1978 PACER-TRACER PULSE WIDTH INSTROMEDIX, INC.
K781457 08/22/1978 FOLEY CATHETERS INTERMED, INC.
K781498 08/30/1978 LIFELINE BIPOLAR PACING LEAD MOD. 466-01 INTERMEDICS, INC.
K781497 08/30/1978 LIFELINE PACING LEAD MODEL 465-01 INTERMEDICS, INC.
K781499 08/30/1978 LIFELINE PACING LEAD MODEL 467-01 INTERMEDICS, INC.
K781327 08/01/1978 PULSE GENERATOR, MODEL 240, EXTERNAL INTERMEDICS, INC.
K781420 08/15/1978 SPECIALTY SPONGES IPCO CORP.
K781357 08/08/1978 T.E.D. SEQUENTIAL COMPRESSION SLEEVES KENDALL RESEARCH CENTER
K781375 08/09/1978 COMFORM ABSORBANT INCONTINENCE PADS KIMBERLY-CLARK CORP.
K781433 08/21/1978 AKRON MALE EXTERNAL CATHETER LATEX IND., INC.
K781339 08/03/1978 ENDOTRACHEAL TUBE LIFE-LINE PRODUCTS, INC.
K781475 08/28/1978 ELECTRODE IMPEDANCE TESTER-MODEL 500 LIFE-TECH INSTRUMENTS, INC.
K781461 08/18/1978 MODEL 7320 VISUAL STIMULATOR LIFE-TECH INSTRUMENTS, INC.
K781476 08/28/1978 MULAR GOLD LEAF ELECTRODE MODEL 7501 LIFE-TECH INSTRUMENTS, INC.
K781474 08/28/1978 PREAMPLIFIER MODELS 8101PI & 8102PI LIFE-TECH INSTRUMENTS, INC.
K781477 08/28/1978 TRIGLYCERIDES TEST KIT MALLINCKRODT CRITICAL CARE
K781334 08/02/1978 DISPOSABLE SYRINGE FILL TUBE MALLINCKRODT GROUP, INC.
K781356 08/07/1978 IMPLANT, EYE SPHERE MCGHAN MEDICAL CORP.
K781491 08/28/1978 PRO-MOLD, CUSTOM EAR MCGHAN MEDICAL CORP.
K781358 08/08/1978 SEQUENTIAL CUFF INFLATION DEVICE MEDASONICS, INC.
K781336 08/03/1978 SURGITEK DISPOSABLE FLO-RESTER MEDICAL ENGINEERING CORP.
K781383 08/11/1978 INTERFACE CARDIOTOMY BLOOD FILTER MEDICAL, INC.
K781417 08/16/1978 PRECISION GAS MIXER MEDICOR USA LTD.
K781352 08/07/1978 STRAIN GAUGE PLETHYSMOGRAPH MEDIMATIC
K781348 08/07/1978 FOCISCAN ECHOVISOR SYSTEM METRIX TEKNIKA, INC.
K781350 08/07/1978 OBJECTS PRECISION HANDLING TEST KIT METRO. HOSPITAL & HEALTH CENTER
K781384 08/11/1978 WRIGHT RAPID STAIN MFG CHEMISTS, INC.
K781392 08/10/1978 CYTOMEGILISH TEST KIT MICROBIOLOGICAL ASSOC.
K781492 08/28/1978 SERIES 7000 GAS MACHINE NARCO MCKESSON CO.
K781495 08/30/1978 RIANEN ASSAY SYSTEM, 125I KIT NEW ENGLAND NUCLEAR
K781396 08/10/1978 CREATININE REAGENT SET NOBEL SCIENTIFIC INDUSTRIES, INC.
K781335 08/02/1978 DIGOXIN RIA (PEG) KIT ORTHO DIAGNOSTICS, INC.
K781435 08/16/1978 ORTHO LOW IONIC SOLUTION ORTHO DIAGNOSTICS, INC.
K781481 08/28/1978 ORTHO*T-3 RIA (PEG) KIT ORTHO DIAGNOSTICS, INC.
K781482 08/28/1978 ORTHO*T-3 UPTAKE KIT ORTHO DIAGNOSTICS, INC.
K781483 08/28/1978 ORTHO*T-4 RIA (PEG) KIT ORTHO DIAGNOSTICS, INC.
K781446 08/23/1978 "C" RING CLINCHER ORTHOPEDIC EQUIPMENT CO., INC.
K781450 08/23/1978 DRIVERS ORTHOPEDIC EQUIPMENT CO., INC.
K781451 08/23/1978 FLAT WRENCH ORTHOPEDIC EQUIPMENT CO., INC.
K781448 08/23/1978 HARRINGTON HOOK CLAMP ORTHOPEDIC EQUIPMENT CO., INC.
K781449 08/23/1978 HARRINGTON SPINAL ELEVATOR ORTHOPEDIC EQUIPMENT CO., INC.
K781443 08/23/1978 HARRINGTON SPINE INSTRUMENTATION ORTHOPEDIC EQUIPMENT CO., INC.
K781444 08/23/1978 OUTRIGGER DISTRACTION UNIT ORTHOPEDIC EQUIPMENT CO., INC.
K781445 08/23/1978 SPREADER ORTHOPEDIC EQUIPMENT CO., INC.
K781447 08/23/1978 THREADED ROD CLAMP ORTHOPEDIC EQUIPMENT CO., INC.
K781424 08/17/1978 GENERATORS: UDL-201B, BDL-201B, MDL-201B PACESETTER SYSTEMS
K781351 08/07/1978 AURO-BRUSH PARKER LABORATORIES, INC.
K781470 08/28/1978 MODESS* BELTLESS FEMININE NAPKIN PERSONAL PRODUCTS CO.
K781473 08/28/1978 BUCKY WALL STAND PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K781425 08/22/1978 CAP-MOBILE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K781500 08/30/1978 MODEL 845T IMAGING/ERGOMETER TABLE QUINTON, INC.
K781487 08/28/1978 EARLY PREGNANCY DETECTION KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K781458 08/23/1978 RADIOEAR RE SERIES HEARING AIDS RADIOEAR CORP.
K781440 08/18/1978 LENSOMETER MODEL 11 RODENSTOCK INSTRUMENT CORP.
K781489 08/28/1978 ACID PHOSPHATASE DIAG. KIT SCLAVO, INC.
K781459 08/23/1978 MONOJECT SCALE MAGNIFIER SHERWOOD MEDICAL INDUSTRIES
K781496 08/30/1978 XIMATRON IV SIEMENS ELEMA AB
K781400 08/15/1978 HEMOVAC TUBING MATERIAL CHANGE SNYDER LABORATORIES, INC.
K781365 08/07/1978 SPARTA BRONCHIAL BRUSH SPARTA INSTRUMENT CORP.
K781453 08/22/1978 MODEL 770 ARGON LASER SPECTRA-PHYSICS, INC.
K781378 08/10/1978 EMIT N-ACETYLPROCAINAMIDE ASSAY SYVA CO.
K781382 08/11/1978 EMIT PROCAINAMIDE ASSAY SYVA CO.
K781399 08/15/1978 TECA MODEL B9 ELECTROMYOGRAPH TECA, INC.
K781398 08/15/1978 TECA VS6 VIDEO STIMULATOR TECA, INC.
K781503 08/30/1978 TECHNICON STAT/LYTE ISE ELECTROLYTE TECHNICON INSTRUMENTS CORP.
K781426 08/22/1978 CARDIAL PULSE GENERATORS TELECTRONICS, INC.
K781422 08/17/1978 KWIK-FLO URINAL SYSTEM THE GRACE MFG. CO.
K781468 08/24/1978 CONTINUOUS FEED VALVE 2D9024 TRAVENOL LABORATORIES, S.A.
K781467 08/24/1978 U-FLOAT VALVE 2D9023 TRAVENOL LABORATORIES, S.A.
K781454 08/22/1978 LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA UNION CARBIDE CORP.
K781405 08/14/1978 SUITCASE KIDNEY HEMODIALYSIS SYSTEM UNION CARBIDE CORP.
K781502 08/30/1978 HEARING AID, UNITRON MODEL 761P UNITRON INDUSTRIES, INC.
K781439 08/18/1978 HEARING AID, UNITRON MODEL 958 UNITRON INDUSTRIES, INC.
K781434 08/21/1978 HEARING AID, UNITRON MODEL 975 UNITRON INDUSTRIES, INC.
K781379 08/11/1978 MODEL 5000, LIQUID CHROMATOGRAPHY VARIAN ASSOC., INC.
K781518 08/31/1978 PREGELLED DISPOSABLE ELECTRODE VENTE MEDICAL PRODUCTS, INC.
K781430 08/21/1978 PREGELLED DISPOSABLE E.K.G. ELECTRODE VERMONT MEDICAL, INC.
K781325 08/01/1978 MARKII VENTIMASKS VICKERS AMERICA MEDICAL CORP.
K781332 08/02/1978 PEEP/CPAP VALVE VICKERS AMERICA MEDICAL CORP.
K781415 08/15/1978 CANNULA, NASAL, OXYGEN VITALAB PRODUCTS CORP.
K781414 08/15/1978 MASK, OXYGEN, NONBREATHING VITALAB PRODUCTS CORP.
K781413 08/15/1978 MASK, PXYGEN VITALAB PRODUCTS CORP.
K781416 08/15/1978 TUBING, FLEXIBLE, MEDICAL GAS VITALAB PRODUCTS CORP.
K781342 08/04/1978 GLUCOSE TEST WAKO INTL., INC.
K781490 08/28/1978 TILLMAN HIPSURFACE REPLACEMENT WALDEMAR LINK GMBH & CO. KG
K781437 08/18/1978 SURGICAL PREP RAZOR WARREN J. GROSJEAN
K781418 08/16/1978 XOMED TRANSSPHENOIDAL HANDPIECE XOMED, INC.
K781403 08/15/1978 FTA-ABS TEST SYSTEM ZEUS SCIENTIFIC, INC.
K781516 08/31/1978 TEST SYSTEM TISSUE CELL CULTURE SLIDE ZEUS SCIENTIFIC, INC.


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