FDA 510(k) Decisions During September, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K781098 09/29/1978 BRUSH, APPLICATOR 3M COMPANY
K781021 09/27/1978 AIR BUBBLE DETECTOR 3M HEALTH CARE, SARNS
K781406 09/07/1978 HYDRON BURN BANDAGE MANUAL APPLICATION ABBOTT LABORATORIES
K781370 09/20/1978 MS-2 AUTOMATED URINE SCREENING SYSTEM ABBOTT LABORATORIES
K781427 09/27/1978 MS-2 BACTERIAL ID. SYSTEM ABBOTT LABORATORIES
K781228 09/07/1978 PENLIGHTS ABCO DEALERS, INC.
K781343 09/27/1978 RESURFACE PROSHESIS AESCULAP INSTRUMENTS CORP.
K781376 09/14/1978 STANDARDIZE TGCL & TGCH AMERICAN MONITOR CORP.
K781410 09/27/1978 RIALYZE VITAMIN B-12 TEST AMES DIV., MILES LABORATORIES, INC.
K781053 09/07/1978 DINAMAP MODEL 846 APPLIED MEDICAL RESEARCH
K781064 09/07/1978 DINAMAP MODEL 848 APPLIED MEDICAL RESEARCH
K781472 09/27/1978 MITROPHENYL, ALKALINE PHOSPHATES BECKMAN INSTRUMENTS, INC.
K780886 09/01/1978 SYSTEM 6000 AUTOMATED RIA ANALYZER BECKMAN INSTRUMENTS, INC.
K780078 09/14/1978 OXYGENATOR, BUBBLE TYPE BENTLEY LABORATORIES, INC.
K781247 09/14/1978 QUANTICEL-HRP BHP DIAGNOSTIX, INC.
K781387 09/20/1978 INSTA-PULSE HEART RATE MONITOR BIO SIG INSTRUMENTS, INC.
K781397 09/14/1978 EM-V BIOLOGICAL CORP. OF AMERICA
K781385 09/07/1978 DOBBHOFF ENTERIC FEEDING BAG BIOSEARCH MEDICAL PRODUCTS, INC.
K781428 09/11/1978 FLEXTUBES:9", 20", 26" BOURNS MEDICAL SYSTEMS, INC.
K781577 09/27/1978 DISPOSABLE CARDIOTOMY; H-700F, H-700 C.R. BARD, INC.
K781462 09/14/1978 AUTO-FIELD II OPHTHALMIC FIELD SCANNER CAVITRON CORP.
K781014 09/07/1978 AUTOREFRACTOR, SUBJECTIVE CAVITRON CORP.
K781541 09/26/1978 FLOMETER CHEMETRON MEDICAL PRODUCTS, INC.
K781421 09/20/1978 BIOSCAN E12 CLINIFAX INDUSTRIES, LTD.
K781411 09/20/1978 CORNEAL CUTTER AND ACCESSORIES CODMAN & SHURTLEFF, INC.
K781465 09/20/1978 MICROSURGICAL KNIVES, 20, 30, 45 CODMAN & SHURTLEFF, INC.
K780872 09/07/1978 CYTOLOGY BRUSH COOPERVISION, INC.
K781409 09/27/1978 IMMO PHASE, THYROID HORMONE CORNING MEDICAL & SCIENTIFIC
K781528 09/27/1978 COULTER ELECTROLYTE ANALYZER SYSTEM COULTER ELECTRONICS, INC.
K781486 09/27/1978 STERI-VAC POWER UNITS CPAC, INC.
K781140 09/07/1978 CUTTER RESIFLEX FOLEY CATHETERS CUTLER LABORATORIES, INC.
K781407 09/27/1978 ERM-101 CYNERGY
K781595 09/27/1978 BODY-WORN HEARING AID, MODEL 787PP DANAVOX, INC.
K781596 09/27/1978 HEARING AID, MODEL 775 PP/AGC DANAVOX, INC.
K781163 09/26/1978 ELECTRODE, DEIP. DATASCOPE CORP.
K781488 09/27/1978 MVS-MODEL SEU-6, DEU-6 DENTSPLY INTL.
K781526 09/20/1978 SILASTIC U-TUBE KIT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K781214 09/14/1978 CAMERAS, MULTI-IMAGE DUNN INSTRUMENTS, INC.
K781245 09/20/1978 LUNG EXER. BAG, POST-OP, MODIFIED DYTEK CORP.
K781536 09/14/1978 VAC-U-PAC KIDNEY CASSETTE E-Z-EM, INC.
K781535 09/15/1978 AC ADAPTER:MODELS 9525,9526,9527 EDWARDS LABORATORIES
K781178 09/07/1978 PULSE GENERATOR MODEL 208 ELEMA-SCHONANDER, INC.
K781519 09/14/1978 EMI SIMULATOR REMOTE CONTROL CONSOLE EMI MEDICAL, INC.
K781386 09/14/1978 EBS 775 TONOMETER EQUILIBRATED BIO SYSTEMS, INC.
K781509 09/26/1978 ZEE-FRAME EQUILIBRATED BIO SYSTEMS, INC.
K781176 09/07/1978 PATIENT AID, MODEL DM-351 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K781371 09/20/1978 BONE MARROW ASPIRATION KIT FERRIS MFG. CORP.
K781390 09/01/1978 MYCOPLASMA HYORHINIS (BTS-7) FLOW LABORATORIES, INC.
K781508 09/26/1978 WATERPATH SCANNING OPTION G.D. SEARLE AND CO.
K781431 09/07/1978 ELECTRIC CT/T OPERATOR DISPLAY CONSOLE GENERAL ELECTRIC CO.
K781316 09/27/1978 PULSED AND CONTINUOUS SHORTWAVE APPAR. GENERAL THERAPHYSICAL, INC.
K781320 09/27/1978 SHORTWAVE THERAPY APPAR. CURAMED 401 GENERAL THERAPHYSICAL, INC.
K781404 09/07/1978 BED PADS: D-12 AND D-8 GRANT AIRMASS CORP.
K781050 09/26/1978 DLC 500, DOUBLE LUMEN CATHETER HEMODIALYSIS, DIVISION OF THE
K781359 09/26/1978 MODEL 80032A, OBSTETRICAL TELEMETRY HEWLETT-PACKARD CO.
K781360 09/07/1978 MODEL 80100A, PATIENT DATA MEMORY HEWLETT-PACKARD CO.
K780706 09/07/1978 LUMBAR NERVE ROOT SHIELD HEYER SCHULTE CORP.
K781037 09/14/1978 PRESSURE INFUSION DEVICE HINCK MEDICAL, INC.
K781373 09/20/1978 OSTOMY APPLIANCE W/DEODORIZING FILTER HOLLISTER, INC.
K781142 09/14/1978 DISSCAP HOSPAL MEDICAL CORP.
K781608 09/27/1978 CENTRAL PEG TIBIAL COMPONENT HOWMEDICA CORP.
K781105 09/27/1978 TONOMETER, DIGITON ICAL, INC.
K781361 09/14/1978 HEMOGLOBINOMETER MODEL 720 B INNOVATIVE MEDICAL SYSTEMS, INC.
K781173 09/14/1978 COMPUTER INTERFACE IL 814 INSTRUMENTATION LABORATORY CO.
K781081 09/27/1978 EMIT MCA PROGRAM TAPE INSTRUMENTATION LABORATORY CO.
K781457 09/20/1978 FOLEY CATHETERS INTERMED, INC.
K772226 09/27/1978 PACEMAKER, MODEL 225 & 227 INTERMEDICS, INC.
K780899 09/07/1978 FLUORESCENT ANTI-NATIVE DNA TEST KALLESTAD LABORATORIES, INC.
K781357 09/20/1978 T.E.D. SEQUENTIAL COMPRESSION SLEEVES KENDALL RESEARCH CENTER
K781375 09/20/1978 COMFORM ABSORBANT INCONTINENCE PADS KIMBERLY-CLARK CORP.
K781109 09/14/1978 FORCEPS, ELECTROSURGICAL KLI
K781243 09/20/1978 MERCURY DISP. CAPSULE LEE PHARMACEUTICALS
K781475 09/07/1978 ELECTRODE IMPEDANCE TESTER-MODEL 500 LIFE-TECH INSTRUMENTS, INC.
K781474 09/07/1978 PREAMPLIFIER MODELS 8101PI & 8102PI LIFE-TECH INSTRUMENTS, INC.
K781230 09/07/1978 GAVAGE ADMIN. SET MCGAW LABORATORIES
K781491 09/27/1978 PRO-MOLD, CUSTOM EAR MCGHAN MEDICAL CORP.
K781358 09/20/1978 SEQUENTIAL CUFF INFLATION DEVICE MEDASONICS, INC.
K780987 09/28/1978 SOFT SILICONE ELASTOMER SPONGE EXPLANT MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
K781383 09/27/1978 INTERFACE CARDIOTOMY BLOOD FILTER MEDICAL, INC.
K781417 09/20/1978 PRECISION GAS MIXER MEDICOR USA LTD.
K781103 09/27/1978 SPECTRASCAN MEDISHIELD, INC.
K781157 09/20/1978 STIMULATOR, NERVE, TRANSCUTANEOUS MEDTECH INTL., INC.
K781043 09/15/1978 CEA-IMMERSIBLE SEPARATOR MILLIPORE CORP.
K781492 09/11/1978 SERIES 7000 GAS MACHINE NARCO MCKESSON CO.
K781495 09/14/1978 RIANEN ASSAY SYSTEM, 125I KIT NEW ENGLAND NUCLEAR
K781396 09/14/1978 CREATININE REAGENT SET NOBEL SCIENTIFIC INDUSTRIES, INC.
K781435 09/14/1978 ORTHO LOW IONIC SOLUTION ORTHO DIAGNOSTICS, INC.
K781481 09/27/1978 ORTHO*T-3 RIA (PEG) KIT ORTHO DIAGNOSTICS, INC.
K781482 09/27/1978 ORTHO*T-3 UPTAKE KIT ORTHO DIAGNOSTICS, INC.
K781483 09/27/1978 ORTHO*T-4 RIA (PEG) KIT ORTHO DIAGNOSTICS, INC.
K781146 09/14/1978 HEMAC LASER HEMATOLOGY SYSTEM ORTHO INSTRUMENTS
K781446 09/27/1978 "C" RING CLINCHER ORTHOPEDIC EQUIPMENT CO., INC.
K781450 09/27/1978 DRIVERS ORTHOPEDIC EQUIPMENT CO., INC.
K781451 09/27/1978 FLAT WRENCH ORTHOPEDIC EQUIPMENT CO., INC.
K781448 09/27/1978 HARRINGTON HOOK CLAMP ORTHOPEDIC EQUIPMENT CO., INC.
K781449 09/27/1978 HARRINGTON SPINAL ELEVATOR ORTHOPEDIC EQUIPMENT CO., INC.
K781443 09/27/1978 HARRINGTON SPINE INSTRUMENTATION ORTHOPEDIC EQUIPMENT CO., INC.
K781444 09/27/1978 OUTRIGGER DISTRACTION UNIT ORTHOPEDIC EQUIPMENT CO., INC.
K781447 09/27/1978 THREADED ROD CLAMP ORTHOPEDIC EQUIPMENT CO., INC.
K781424 09/27/1978 GENERATORS: UDL-201B, BDL-201B, MDL-201B PACESETTER SYSTEMS
K781470 09/07/1978 MODESS* BELTLESS FEMININE NAPKIN PERSONAL PRODUCTS CO.
K781473 09/11/1978 BUCKY WALL STAND PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K781425 09/11/1978 CAP-MOBILE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K781289 09/14/1978 PREAMPLIFIER MODEL 113 PRINCETON APPLIED RESEARCH CORP.
K781290 09/15/1978 SIGNAL AVERAGER MODEL 4202 PRINCETON APPLIED RESEARCH CORP.
K781277 09/27/1978 STIMULATOR, NERVE, TRANSCUTANEOUS PSITRON
K781500 09/14/1978 MODEL 845T IMAGING/ERGOMETER TABLE QUINTON, INC.
K781458 09/07/1978 RADIOEAR RE SERIES HEARING AIDS RADIOEAR CORP.
K781256 09/20/1978 CATHODE RAY TUBE MED. DISPLAY RAE MEDICAL CORP.
K781255 09/20/1978 DIGITAL PANEL METER RAE MEDICAL CORP.
K781113 09/26/1978 MUSCLE STIMULATOR, ELECTRICAL RICH-MAR CORP.
K781167 09/15/1978 STEMPLEX RICH-MAR CORP.
K781574 09/27/1978 PLASTI-PORE SEPTAL BUTTON RICHARD'S MEDICAL EQUIP., INC.
K781440 09/07/1978 LENSOMETER MODEL 11 RODENSTOCK INSTRUMENT CORP.
K781232 09/27/1978 IPPB ASSEMBLY W/NEBULIZER RTEC
K781231 09/11/1978 OXYGEN SUPPLY TUBE, DISP., PLASTIC RTEC
K781127 09/20/1978 CONNECTING TUBE, CONDUCTIVE, SURG. SEAMLESS HOSPITAL PRODUCTS CO.
K780772 09/01/1978 BJORK-SHILEY CARDIAC HEART VALVE SHILEY, INC.
K781286 09/11/1978 DENTAL X-RAY UNIT SIEMENS CORP.
K781288 09/11/1978 DENTAL X-RAY UNIT HELIODENT 70 SIEMENS CORP.
K781287 09/11/1978 DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH SIEMENS CORP.
K781540 09/14/1978 OPTI 110/12/50 HSG SIEMENS CORP.
K781531 09/14/1978 OPTIPLANIMAT SIEMENS CORP.
K781532 09/14/1978 UROSKOP A AND B SIEMENS CORP.
K781496 09/14/1978 XIMATRON IV SIEMENS ELEMA AB
K781400 09/20/1978 HEMOVAC TUBING MATERIAL CHANGE SNYDER LABORATORIES, INC.
K781292 09/20/1978 CARDIOPNEUMOGRAPH STREET ELECTRONICS CORP.
K781399 09/20/1978 TECA MODEL B9 ELECTROMYOGRAPH TECA, INC.
K781503 09/27/1978 TECHNICON STAT/LYTE ISE ELECTROLYTE TECHNICON INSTRUMENTS CORP.
K781426 09/07/1978 CARDIAL PULSE GENERATORS TELECTRONICS, INC.
K781090 09/07/1978 GENERATOR, CARDIAC PULSE, 250B TELECTRONICS, INC.
K780940 09/27/1978 GENERATOR, PULSE, MODEL 160B TELECTRONICS, INC.
K781073 09/27/1978 PULMO-SONIC THE DEVILBISS CO.
K781422 09/07/1978 KWIK-FLO URINAL SYSTEM THE GRACE MFG. CO.
K781139 09/26/1978 MUSCLE STIMULATOR, ELECTRONIC THOR MEDICAL INSTRUMENTS, INC.
K781597 09/27/1978 PM 2000 AUTOMATIC PATIENT CHAIR TIME MOTION SYSTEM CO.
K781468 09/07/1978 CONTINUOUS FEED VALVE 2D9024 TRAVENOL LABORATORIES, S.A.
K781467 09/07/1978 U-FLOAT VALVE 2D9023 TRAVENOL LABORATORIES, S.A.
K781454 09/20/1978 LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA UNION CARBIDE CORP.
K781502 09/11/1978 HEARING AID, UNITRON MODEL 761P UNITRON INDUSTRIES, INC.
K781513 09/14/1978 HEARING AID, UNITRON MODEL 960PL UNITRON INDUSTRIES, INC.
K781174 09/14/1978 CLINAC 12/10 VARIAN ASSOC., INC.
K781379 09/14/1978 MODEL 5000, LIQUID CHROMATOGRAPHY VARIAN ASSOC., INC.
K781325 09/27/1978 MARKII VENTIMASKS VICKERS AMERICA MEDICAL CORP.
K781415 09/07/1978 CANNULA, NASAL, OXYGEN VITALAB PRODUCTS CORP.
K781414 09/07/1978 MASK, OXYGEN, NONBREATHING VITALAB PRODUCTS CORP.
K781413 09/07/1978 MASK, PXYGEN VITALAB PRODUCTS CORP.
K781416 09/11/1978 TUBING, FLEXIBLE, MEDICAL GAS VITALAB PRODUCTS CORP.
K781490 09/20/1978 TILLMAN HIPSURFACE REPLACEMENT WALDEMAR LINK GMBH & CO. KG
K781264 09/20/1978 PAB CONVENIENCE TRAY WATERS ASSOC., INC.
K781516 09/27/1978 TEST SYSTEM TISSUE CELL CULTURE SLIDE ZEUS SCIENTIFIC, INC.


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