FDA 510(k) Applications Received During March, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K770429 03/07/1977 CANNULAE, AORTIC, ARCH, HIGH FLOW 3M HEALTH CARE, SARNS
K770430 03/07/1977 CATHETER, CURVED LEFT HEART VENT 3M HEALTH CARE, SARNS
K770431 03/07/1977 CATHETER, TWO STAGE VENOUS RETURN 3M HEALTH CARE, SARNS
K770403 03/03/1977 CATHETER-THRU-NEEDLE DEVICE ABBOTT LABORATORIES
K770404 03/03/1977 OBTURATOR ABBOTT LABORATORIES
K770518 03/18/1977 PIGGYBACK VENOSET W/0.22 FILTER ABBOTT LABORATORIES
K770474 03/11/1977 THYROSCREEN TM T4 DIAGNOSTIC KIT ABBOTT LABORATORIES
K770596 03/28/1977 CONNECTORS ABCO DEALERS, INC.
K770594 03/28/1977 LABORATORY EXPENDABLE PRODUCTS ABCO DEALERS, INC.
K770595 03/28/1977 SUTURE REMOVAL SET ABCO DEALERS, INC.
K770513 03/17/1977 MASK, SURGICAL, DISP ACME AUTOMATIC DISPOSABLE
K770414 03/04/1977 PROBE RETRACTOR, PART #S-2L8-6 ACME UNITED CORP.
K770418 03/04/1977 RETRACTOR, SKIN HOOK ACME UNITED CORP.
K770481 03/11/1977 SHEAR, PLASTIC HANDLE UTILITY S-475-7 ACME UNITED CORP.
K770588 03/28/1977 COTTON BALL KIT AMERICAN HOSPITAL SUPPLY CORP.
K770479 03/11/1977 LACERATION KIT AMERICAN HOSPITAL SUPPLY CORP.
K770486 03/14/1977 SHEET KIT, STRETCHER, DISPOSABLE AMERICAN HOSPITAL SUPPLY CORP.
K770504 03/16/1977 REAGENT SYSTEM AMERICAN MONITOR CORP.
K770528 03/18/1977 NEEDLE, MEMBRANE AMERICAN VIGGO
K770397 03/02/1977 MONITOR, RADIOISOTOPE, MODEL 9273A AMERSHAM CORP.
K770398 03/02/1977 MINICON AMICON, INC.
K770416 03/04/1977 LEAD, HEART, BUTTERFLY CLAMP ARCO MEDICAL PRODUCTS CO.
K770461 03/09/1977 ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU. ARROW INTL., INC.
K770462 03/09/1977 PUNCTURE KIT, INTERNAL JUGULAR ARROW INTL., INC.
K770441 03/07/1977 GAR, COLUMBIA, W/5% HORSE BLOOD BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770401 03/02/1977 LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770400 03/02/1977 REAGENT, AMYLASE LIPASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770465 03/10/1977 RIA-120 AND ESTRIOL REAGENT SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770602 03/30/1977 VALVE, ASCITES, LAVEEN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770570 03/25/1977 CALCIUM/MAGNESIUM ANALYZER BECKMAN INSTRUMENTS, INC.
K770572 03/25/1977 DP-5000 DATA REDUCTION SYSTEM BECKMAN INSTRUMENTS, INC.
K770426 03/07/1977 OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE BEL-MED, INC.
K770582 03/28/1977 LENS, CONTACT, HARD BEREA CONTACT LENS, INC.
K770555 03/21/1977 CPK ISOENZYME CONTROL BIO-REAGENTS & DIAGNOSTICS, INC.
K770406 03/03/1977 TECHNICON SMA & AAII SYSTEMS BOEHRINGER LABORATORIES
K770423 03/07/1977 URINE TESTER, MODEL NO. 707 BROTHER SCIENTIFIC PRODUCTS, INC.
K770581 03/28/1977 CORRUGATED TUBING, 770 & 771 C.D. & F. CORP.
K770514 03/17/1977 STERILIZER WRAP C.R. BARD, INC.
K770536 03/21/1977 STEAM STERILIZER, 3000 CASTLE CO.
K770532 03/21/1977 PC-30 PULMONARY COMPUTER CAVITRON CORP.
K770433 03/07/1977 Q-TIPS CHESEBROUGH-POND'S U.S.A. CO.
K770480 03/11/1977 IN VITRO T-3 UPTAKE TEST CLINICAL ASSAYS, INC.
K770578 03/28/1977 PARALLEL PLATE DIALYZER COBE LABORATORIES, INC.
K770498 03/14/1977 PRESERVE LUBRICANT CODE NO. 43=4035 CODMAN & SHURTLEFF, INC.
K770413 03/04/1977 CUSHIONS, DENTURE ADHESIVE, ALL-DAY COMBE, INC.
K770557 03/21/1977 DRAINAGE BAG, 4000 ML. CONCORD LABORATORIES, INC.
K770497 03/14/1977 DRAINAGE UNIT, COMBINATION CONCORD LABORATORIES, INC.
K770496 03/14/1977 UNIVERSAL TRAY CONCORD LABORATORIES, INC.
K770522 03/18/1977 CATHETER, GRUNTZIG, BALLON COOK, INC.
K770523 03/18/1977 NEEDLE, BIOPSY, BOYD, LUNG COOK, INC.
K770559 03/23/1977 C-L0L CARDIAC PACEMAKER CORATOMIC, INC.
K770478 03/11/1977 ADAPTER, CORDIS CORDIS CORP.
K770535 03/21/1977 C-DAK 3500 CORDIS CORP.
K770469 03/10/1977 CUTTER TUNGSTEN CARBIDE BURS CUTTER LABORATORIES, INC.
K770468 03/10/1977 UNIPOLAR LEAD CONFIGURATION CONDUCTOR DAIG CORP.
K770606 03/31/1977 ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH DAMON CORP.
K770546 03/21/1977 BLOOD RESERVOIR DELTA MEDICAL INDUSTRIES
K770556 03/21/1977 PRO-KUP DENTAL CONTROL PRODUCTS
K770599 03/29/1977 NUVA-LITE II PHOTO-CURE UNIT DENTSPLY INTL.
K770421 03/07/1977 COMPONENTS, ANKLE, TRIAL, CON-AXIAL DEPUY, INC.
K770420 03/07/1977 FORCEPS, ANKLE INSERTING, CON-AXIAL DEPUY, INC.
K770492 03/14/1977 CRACK DETECTOR, DEN-MAT DEY-MAT, INC.
K770521 03/18/1977 ELECTROCARDIOGRAPHIC ELECTRODES, DISP. DOBRE, INC.
K770554 03/21/1977 NARKOMED ANESTHESIA MACHINE DRAEGER MEDICAL, INC.
K770614 03/31/1977 MONITOR, GAS MANIFOLD DYNATECH CRYOMEDICAL CO.
K770574 03/28/1977 CRONEX QUANTA III INTENSIFYING SCREENS E.I. DUPONT DE NEMOURS & CO., INC.
K770503 03/16/1977 LOUISVILLE CLAMP PRODUCT #65-172 EDWARD WECK, INC.
K770427 03/07/1977 CATHETER INTRODUCER KIT ELECTRO-CATHETER CORP.
K770590 03/28/1977 SURGI-KIT ETHOX CORP.
K770516 03/18/1977 MEMBRANE SOURCE-EX SERIES DIALYZER CART. EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K770567 03/25/1977 LIGHT, EXAMINATION, MEDICAL (MEL) FIBER OPTICS ENGINEERING, INC.
K770568 03/25/1977 SURGICAL ILLUMINATOR (SIL) FIBER OPTICS ENGINEERING, INC.
K770494 03/14/1977 BLOOD GAS ANALYZER-CALIBRATION GAS GARDNER CRYOGENICS
K770440 03/07/1977 IMPLANT, DENTAL, PYROLITE CARBON ENDO. GENERAL ATOMIC CO.
K770476 03/11/1977 EXAM GOWN GENERAL MEDICAL CO.
K770488 03/14/1977 ISOLATION GOWN GENERAL MEDICAL CO.
K770583 03/28/1977 MEDI-PAK LEMON GLYCEOIN SWABS GENERAL MEDICAL CO.
K770550 03/21/1977 ATYPIA PROFILE MONITOR GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770613 03/31/1977 LDH ULTRAZYME PLUS HARLECO DIAGNOSTICS
K770558 03/22/1977 ISODYNE HMW INDUSTRIES
K770467 03/10/1977 IN VITRO DIAGNOSTIC TEST HOFFMANN-LA ROCHE, INC.
K770428 03/07/1977 VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. HOLCO INSTRUMENT CORP.
K770439 03/07/1977 STOMA BAG W/SKIN BARRIER SEAL RING HOLLISTER, INC.
K770408 03/04/1977 KARAYA GUM POWDER, OSTOMY HOWMEDICA CORP.
K770471 03/10/1977 KERBOULL-CHARNLEY CUP SPECIAL MODEL HOWMEDICA CORP.
K770473 03/10/1977 LAGRANGE LETOURNEL TOTAL HIP FEMORAL HOWMEDICA CORP.
K770472 03/10/1977 PROSTHESIS, VIDAL TOTAL HIP HOWMEDICA CORP.
K770487 03/14/1977 LIGHTWEIGHT PLASTIC CANNULA HUDSON OXYGEN THERAPY SALES CO.
K770548 03/21/1977 IMMUNOPLATE III RADIO IMMUNODIFFUSION HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770547 03/21/1977 LAS-R TM HUMAN COMPLEMENT C4 TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770438 03/07/1977 CART, PROCEDURES I E INDUSTRIES
K770437 03/07/1977 TABLE, EXAMINATION I E INDUSTRIES
K770527 03/18/1977 CANDIDA IMMUNODIFFUSION KIT I M, INC.
K770451 03/08/1977 ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL ICN PHARMACEUTICALS, INC.
K770458 03/08/1977 BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. ICN PHARMACEUTICALS, INC.
K770449 03/08/1977 CALCIUM PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770450 03/08/1977 CHLORIDE PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770457 03/08/1977 CHOLESTEROL PROCEDURE, TEKPOINT TOTAL ICN PHARMACEUTICALS, INC.
K770454 03/08/1977 CREATININE PROCEDURE, TEKPOINT ICN PHARMACEUTICALS, INC.
K770455 03/08/1977 GLUCOSE PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770453 03/08/1977 PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE ICN PHARMACEUTICALS, INC.
K770456 03/08/1977 PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770452 03/08/1977 PROTEIN PROCEDURE, TEKPOINT TOTAL ICN PHARMACEUTICALS, INC.
K770459 03/08/1977 URIC ACID PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770549 03/21/1977 PEDIATRIC ANESTHESIA CIRCUIT INSPIRON CORP.
K770412 03/04/1977 PROPHALACTICS JAMAR HEALTH PRODUCTS
K770562 03/23/1977 HANDLER CATHETER JANET BEACH, LTD.
K770589 03/28/1977 FILTER, INTRAVENOUS W/AUTO AIR VENT JELCO LABORATORIES
K770533 03/21/1977 BAND-AID BRAND ADHES. BAND.-SHEER STRIPS JOHNSON & JOHNSON PROFESSIONALS, INC.
K770410 03/04/1977 BANDAGE COMPRESS 2", 3", 4" JOHNSON & JOHNSON PROFESSIONALS, INC.
K770419 03/04/1977 CENTURION JOHNSON & JOHNSON PROFESSIONALS, INC.
K770566 03/24/1977 IMMUNOELECTROPHORESIS PROFILE KIT KALLESTAD LABORATORIES, INC.
K770520 03/18/1977 RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 KALLESTAD LABORATORIES, INC.
K770417 03/04/1977 ANIMATOR KDK MEDICAL PRODUCTS
K770484 03/14/1977 FLUOR. CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K770579 03/28/1977 CATHETER, URETHRAL PRESSURE, UPE-10 & 12 LIFE-TECH INSTRUMENTS, INC.
K770415 03/04/1977 HUMIDIFIER, DISPOSABLE M.G. HUMIDIFIERS, INC.
K770436 03/07/1977 EXERCISER, EXTENSOR WAND MADDAK, INC.
K770553 03/21/1977 AUDIOMETER, DIAG., ADVANCED, MA-22 MAICO HEARING INSTRUMENTS, INC.
K770604 03/31/1977 RIA-DAC TM HTSH KIH MALLINCKRODT CRITICAL CARE
K770564 03/24/1977 URIC ACID TEST KIT MALLINCKRODT CRITICAL CARE
K770396 03/01/1977 DRAPES, MODESTY MARK ONE HEALTHCARE PRODUCTS
K770482 03/14/1977 CATHETER, SINGLE PUNCTURE "Y" MDL MEDICAL DEVICE LABORATORIES, INC.
K770507 03/17/1977 PULSE GENERATOR, LITKICRON MODEL 3-70H MEDCOR, INC.
K770432 03/07/1977 MICROFLUSH MEDEX, INC.
K770552 03/21/1977 CATHETER, KIDNEY DIALYSIS, HEMO-CATH II MEDICAL DISPOSABLES INTL., INC.
K770508 03/17/1977 SMAC SYSTEM MID TECH, INC.
K770506 03/16/1977 IN VITRO DIAGNOSTIC REAGENTS NORWOOD SCIENTIFIC ASSOCIATES, INC.
K770601 03/30/1977 ANALYZER, SODIUM/POTASSIUM NOVA L NOVA BIOMEDICAL CORP.
K770411 03/04/1977 DIGI TROL TM-RX & DIGI TROL TM-TX NUCLEAR MEDICAL LABORATORIES, INC.
K770597 03/29/1977 DASP TM ANTI-RABBIT ORGANON, INC.
K770603 03/30/1977 HYPRONOSTICON TM ORGANON, INC.
K770605 03/31/1977 TUBES, HYDROLYSIS, CALIBRATED ORGANON, INC.
K770466 03/10/1977 STOCKINGS, RVS TM PARKE-DAVIS CO.
K770499 03/14/1977 PATIENT TURNING AND REPOSITIONING G DEV. PATIENT HEALTHGUARDS CORP.
K770573 03/25/1977 ACTA-SCANNER R 0200FS PFIZER MEDICAL SYSTEMS, INC.
K770425 03/07/1977 NEEDLES, STERILE, AIRWAY PFIZER PHARMACEUTICALS
K770489 03/14/1977 CATHETER WITH HARD VALVE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770490 03/14/1977 DRAINAGE BAG, IMPROVED, FLAT PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770463 03/09/1977 MASK, SURGICAL, FACE, DISPOSABLE PRECEPT, INC.
K770580 03/28/1977 PEAK FLOW METER PROJECTS IN HEALTH
K770402 03/03/1977 RADIOEAR MODEL 1072 RADIOEAR CORP.
K770598 03/29/1977 ENDODONTIC INSTRUMENTS, R&R CUTWELL RANSOM AND RANDOLPH
K770524 03/18/1977 TRANSDUCER PROTECTOR, RT-901, RT-902 RENAL SYSTEMS, INC.
K770409 03/04/1977 STERI-STOR TM RESEARCH SURGICAL SYSTEMS
K770501 03/15/1977 KNEE CUFF FOR EXPRESSING FLUID ROBERT R. MOORE
K770517 03/18/1977 NF DEVICE RPR, INC.
K770539 03/21/1977 FORCEPS, HAEM, DEEP OPERATION, 20&22 CM. SEA-PAC TRADING CORP.
K770538 03/21/1977 FORCEPS, HAEMOSTATIC, 14 16,&18 CM. LONG SEA-PAC TRADING CORP.
K770540 03/21/1977 FORCEPS, MOSQUITO STYLE, 12.5 CM. SEA-PAC TRADING CORP.
K770544 03/21/1977 SCISSORS, BANDAGE, 15,18,20CM., ANGULAR SEA-PAC TRADING CORP.
K770542 03/21/1977 SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM. SEA-PAC TRADING CORP.
K770541 03/21/1977 SCISSORS, SURGICAL, 12.5,14,16 & 18 CM. SEA-PAC TRADING CORP.
K770543 03/21/1977 SCISSORS, SURGICAL, ANGULAR, 14 CM. SEA-PAC TRADING CORP.
K770510 03/17/1977 CANNULA, INTRAVENOUS, TEFLON SHERWOOD MEDICAL INDUSTRIES
K770512 03/17/1977 CANNULA, INTRAVENOUS, "R" SHERWOOD MEDICAL INDUSTRIES
K770511 03/17/1977 CANNULA, INTRAVENOUS, HEPARINIZED SHERWOOD MEDICAL INDUSTRIES
K770477 03/11/1977 CITADEL REFERENCE ELECTRODE SHERWOOD MEDICAL INDUSTRIES
K770442 03/07/1977 SUMP DRAIN, W/FILTER, ARGYLE EDLICH SHERWOOD MEDICAL INDUSTRIES
K770577 03/28/1977 DETER. OF PHOSPHOHEXOSE ISOMERASE SIGMA CHEMICAL CO.
K770495 03/14/1977 QUANTI. COLORI. DET. OF SERUM IRON SIGMA CHEMICAL CO.
K770519 03/18/1977 REAGENT SYSTEM 153-UV SIGMA CHEMICAL CO.
K770505 03/10/1977 SHAKE-N-WARM SIGNAL WEST
K770483 03/14/1977 CHOLESTEROL REAGENT SMITH KLINE DIAGNOSTICS, INC.
K770464 03/04/1977 TOOTHBRUSH, PLAK-A-DENT SMITH, RANSCHT, POLLOCK, MANOS & CONNOR
K770447 03/08/1977 EPC INSTICKS STIMULATION TECHNOLOGY, INC.
K770448 03/08/1977 INS - T.E.N.S. STIMULATION TECHNOLOGY, INC.
K770575 03/28/1977 ECHOENCEPHALOGRAPH, DIGITAL, 1000 STORZ INSTRUMENT CO.
K770585 03/28/1977 AEROSOL T ADAPTER, #752 SURGICOT, INC.
K770593 03/28/1977 CORRUGATED TUBING #770 & 771 SURGICOT, INC.
K770586 03/28/1977 UNIVERSAL MOUTHPIECE, #750 SURGICOT, INC.
K770587 03/28/1977 VENTILATOR ADAPTOR, #751 SURGICOT, INC.
K770560 03/23/1977 BARRIER O.B. PACK IV SURGIKOS, INC.
K770592 03/28/1977 CYTOLOGY FIXATIVE SURGIPATH MEDICAL INDUSTRIES, INC.
K770405 03/03/1977 OVERLOAD WARNING DEVICE SYNTHES (USA)
K770422 03/07/1977 CATHETER, SURFLO, I.V. TERUMO AMERICA, INC.
K770526 03/18/1977 DIGITAL SCANNER THE PERKIN-ELMER CORP.
K770424 03/07/1977 OXYGEN TWMER, MODEL SST TIMETER INSTRUMENT CORP.
K770475 03/11/1977 PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2 TRAVENOL LABORATORIES, S.A.
K770493 03/14/1977 TRAVACATH TRAVENOL LABORATORIES, S.A.
K770571 03/25/1977 TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS TRAVENOL LABORATORIES, S.A.
K770500 03/15/1977 3 PORT LUER UNIMETRICS CORP.
K770460 03/08/1977 CENTRIFI CHEM CALCIUM REAGENT UNION CARBIDE CORP.
K770530 03/21/1977 CLEON IMAGER UNION CARBIDE CORP.
K770515 03/17/1977 DISPENSER, TECHNETIUM, CLINTICHEM UNION CARBIDE CORP.
K770531 03/21/1977 UNICAM I UNION CARBIDE CORP.
K770529 03/21/1977 UNICET I UNION CARBIDE CORP.
K770569 03/25/1977 CATHETER, EMBOLECTOMY, UMI UNIVERSAL MEDICAL INSTRUMENT CORP.
K770561 03/23/1977 CATHETER,PERCUTANEOUS INTRODUC. & SHEATH USCI, DIV. C.R. BARD, INC.
K770443 03/07/1977 SPECTROPHOTOMETER ANALYSIS SYS., AA-175 VARIAN ASSOC., INC.
K770444 03/07/1977 SPECTROPHOTOMETER ANALYSIS SYS., AA-375 VARIAN ASSOC., INC.
K770600 03/29/1977 OROPHARYNGEAL SUCTION AIRWAY W.H. WALL, D.D.S.
K770446 03/07/1977 SPONGES, LAPAROTOMY WALPAK CO.
K770534 03/21/1977 THERAPEUTIC APPARATUS, DIERKER TYPE WELL BEING ENT.
K770611 03/31/1977 PARALLEL BARS WILL ROSS CO.
K770612 03/31/1977 SPLINT, BOHLER WILL ROSS CO.
K770609 03/31/1977 TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT WILL ROSS CO.
K770509 03/17/1977 TABLE, MASSAGE AND TREATMENT WILL ROSS CO.
K770610 03/31/1977 TABLE, TREATMENT & TRACTION, HI-LO WILL ROSS CO.
K770607 03/31/1977 TRACTION HARNESS WILL ROSS CO.
K770399 03/02/1977 VALVE FOR CLOSED SYS. URINARY DRAINAGE WILL ROSS CO.
K770608 03/31/1977 WALKING AID WILL ROSS CO.
K770545 03/21/1977 DURA-VAC WILLIAMS GOLD REFINING CO., INC.
K770407 03/04/1977 SHIELD, DENTAL X-RAY, PROTECTIVE WORLDWIDE DENTAL, INC.
K770470 03/10/1977 WORTHINGTON BUN WORTHINGTON BIOCHEMICAL CORP.


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