BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TOPS DISPOS. INFUSION SET/HEMODIALYSIS

    K Number: K841119 · Decision Apr 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    12
    Review Days
    36

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    Basic Information

    Device Name
    TOPS DISPOS. INFUSION SET/HEMODIALYSIS
    K Number
    K841119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Top Surgical Manufacturers Co.
    Date Received
    March 15, 1984
    Decision Date
    April 20, 1984
    Product Code
    KNZ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNZ Accessories, A-V Shunt

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    Other Clearances by Top Surgical Manufacturers Co.

    K Number Device Name
    K844343 TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
    K843415 TOP HYPODERMIC SYRINGE LUER LOCK
    K843313 TOP DISPOSABLE SPINAL NEEDLE
    K843414 TOP HYPODERMIC SYRINGE PISTON
    K841025 TOP DISPOSABLE INFUSION SET
    K832624 TOP VENULA I.V. CATHETER SET
    K832625 TOP THREE WAY STOPCOCK
    K832626 TOP STERILE DISPOS. HYPODERMIC NEEDLES
    K832622 WINGED INFUSION SET
    K832621 TOP DISPOSABLE PLASTIC SYRINGES
    Search all 12 clearances from Top Surgical Manufacturers Co. →