BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIALYIS START CARE KIT

    K Number: K802361 · Decision Jan 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    112

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    Basic Information

    Device Name
    DIALYIS START CARE KIT
    K Number
    K802361
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Med-Pak Corp.
    Date Received
    September 26, 1980
    Decision Date
    January 16, 1981
    Product Code
    FKG
    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
    FKG Tray, Start/Stop (Including Contents), Dialysis

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    Other Clearances by Med-Pak Corp.

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