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510(k) Data Aggregation

    K Number
    K061466
    Device Name
    INTIMOL
    Manufacturer
    DLC LABORATORIES, INC.
    Date Cleared
    2006-12-04

    (192 days)

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

    DLC LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTIMOL™ 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
    INTIMOL™ is a non-sterile, aqueous-based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, non-irritating, non-greasy, non-staining, gel-like liquid and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility test results. This device is not a contraceptive or spermicide, nor does it contain any such component. The product is packaged in a plastic bottle with a flip-top cap.
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