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510(k) Data Aggregation

    K Number
    K980948
    Device Name
    VED VALU- VACUUM ERECTION DEVICE
    Manufacturer
    MISSION PHARMACAL COMP
    Date Cleared
    1998-06-25

    (104 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    MISSION PHARMACAL COMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring. Vacuum Pump - used to create an erection in men with erectlie dysfunction by means of an applied vacuum to the penis, which draws blood into the penlle corpora cavernosa causing the penis to become erect and rigid. Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the ald of a vacuum pump. VED VALU and VED VALU ULTRA are designed to help you create an erection sufficient to penetrate the vagina and have sexual intercourse. They are intented for use by men who have full or parlal impotence. NOTE: Neither the VED VALU nor the VED VALU ULTRA is a contraceptive.
    Device Description
    The VED VALU and VED VALU ULTRA vacuum erection devices consist of two main parts: the vacuum pump and constriction ring.
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