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510(k) Data Aggregation

    K Number
    K043480
    Device Name
    ENHANCE CLITORAL STIMULATION AID
    Manufacturer
    GYNAVATIONS, INC.
    Date Cleared
    2005-06-08

    (174 days)

    Product Code
    NBV
    Regulation Number
    884.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNAVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enhance CSA is Indicated for women with the following symptoms of Female Sexual Arousal Disorder (FSAD): difficulty with arousal (and lubrication), sexual desire and ability to achieve orgasm.
    Device Description
    Not Found
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