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510(k) Data Aggregation

    K Number
    K974215
    Device Name
    VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
    Manufacturer
    VETCO, INC.
    Date Cleared
    1998-02-19

    (101 days)

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

    VETCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the device is to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings. For men who are able to achieve an erection but not maintain it, the application of a constriction ring at the base of the penis can sufficiently reduce venous leak to maintain the erection. In this instance, they may not be required to use the vacuum device.
    Device Description
    Vacuum Device and Constriction Ring Set
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