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    K Number
    K974040
    Device Name
    C3 EXTERNAL MALE BLADDER CONTROL DEVICE
    Manufacturer
    TIMM RESEARCH CO.
    Date Cleared
    1998-07-14

    (263 days)

    Product Code
    FHA
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIMM RESEARCH CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.
    Device Description
    The C3® External Male Bladder Control Device is a disposable, externally applied occlusive device intended to manage urinary incontinence in males. The male urethra is occluded by applying an external force on the base of the dorsal side of the penile shaft by means of a clamp.
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