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

    UROMED PATCH

    K Number: K974600 · Decision Mar 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    10
    Review Days
    112

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    Basic Information

    Device Name
    UROMED PATCH
    K Number
    K974600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5160
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uromed Corp.
    Date Received
    December 9, 1997
    Decision Date
    March 31, 1998
    Product Code
    MNG
    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
    MNG External Urethral Occluder, Urinary Incontinence-Control, Female

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