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

    BOUSER'S URINAL

    K Number: K970465 · Decision Dec 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    314

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    Basic Information

    Device Name
    BOUSER'S URINAL
    K Number
    K970465
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Polymers
    Date Received
    February 7, 1997
    Decision Date
    December 18, 1997
    Product Code
    EXJ
    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
    EXJ Device, Incontinence, Urosheath Type, Sterile

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