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

    ILC LEG BAG HOLDER

    K Number: K903611 · Decision Oct 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    17
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    ILC LEG BAG HOLDER
    K Number
    K903611
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Inman Liebelt Corp.
    Date Received
    August 9, 1990
    Decision Date
    October 26, 1990
    Product Code
    FAQ
    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
    FAQ Bag, Urine Collection, Leg, For External Use, Sterile

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