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510(k) Data Aggregation

    K Number
    K974196
    Device Name
    MEGAVAC SYSTEM
    Manufacturer
    BARRY J. KAPLAN, INC.
    Date Cleared
    1998-05-12

    (186 days)

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

    BARRY J. KAPLAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mega Vac System creates and maintains penile erection in impotent men.
    Device Description
    External Penile Rigidity Device including Vacuum Pump and Constriction Rings
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