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510(k) Data Aggregation

    K Number
    K021125
    Device Name
    SENSUA!
    Manufacturer
    AAC CONSULTING GROUP, INC.
    Date Cleared
    2002-10-25

    (200 days)

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

    AAC CONSULTING GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.
    Device Description
    SENSUA! is a clear, colorless personal lubricant composed of: purified water. Propylene glycol, L-arginine, Hydroxyethyl cellulose, Methylparaben and other ingredients.
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    K Number
    K991469
    Device Name
    AWARE PAD
    Manufacturer
    AAC CONSULTING GROUP, INC.
    Date Cleared
    1999-07-20

    (83 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAC CONSULTING GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aware™ Pad is indicated as an aid for performing breast self-examination.
    Device Description
    Aware TM Pad is a thin polyurethane bladder, 9.5 inches in diameter containing a small quantity of silicone fluid. The very thin nature of the polyester polyurethane allows the pad to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible bladder, provides easy sliding between the upper and lower surfaces of the bladder. Therefore, when properly used between the finger and the soft breast tissues of the patient, a reduction of friction is observed.
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