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510(k) Data Aggregation

    K Number
    K970465
    Device Name
    BOUSER'S URINAL
    Manufacturer
    GENERAL POLYMERS
    Date Cleared
    1997-12-18

    (314 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
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    Applicant Name (Manufacturer) :

    GENERAL POLYMERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.
    Device Description
    Not Found
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