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

    MALE URINARY STRESS PAD*

    K Number: K862877 · Decision Nov 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    417
    Registration Numbers
    418
    Same Product Code
    55
    Applicant Total
    81
    Review Days
    112

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    Basic Information

    Device Name
    MALE URINARY STRESS PAD*
    K Number
    K862877
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5920
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    July 30, 1986
    Decision Date
    November 19, 1986
    Product Code
    EYQ
    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
    EYQ Garment, Protective, For Incontinence

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