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    K Number
    K020512
    Device Name
    MTI ST#1 SILICONE PESSARY
    Manufacturer
    MEDICAL TECHNOLOGY AND INNOVATIONS, INC.
    Date Cleared
    2002-05-16

    (90 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL TECHNOLOGY AND INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.
    Device Description
    The MTI ST#1 Silicone Pessary is geometrically shaped such that when inserted in the patient's vagina, the urethra is aligned between the legs of the device and the bladder is fully supported, thus allowing the bladder to function normally.
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