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510(k) Data Aggregation

    K Number
    K051668
    Device Name
    THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
    Manufacturer
    Date Cleared
    2005-07-08

    (16 days)

    Product Code
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GOODMARK USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
    Device Description
    The Art of Intimacy Response ™ is a homogenous blend of fluids. It is specifically formulated to be a clear, non-irritating, non-staining, non-greasy, medium viscosity liquid gel and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The Art of Intimacy Response ™ is not a contraceptive or spermicide, nor does it contain any such component.
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