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

    BARD LEG BAG HOLDER

    K Number: K926035 · Decision Dec 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    17
    Applicant Total
    645
    Review Days
    16

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    Basic Information

    Device Name
    BARD LEG BAG HOLDER
    K Number
    K926035
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    December 1, 1992
    Decision Date
    December 17, 1992
    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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