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510(k) Data Aggregation

    K Number
    K062682
    Device Name
    CVS PERSONAL LUBRICANT AND MOISTURIZER
    Manufacturer
    LAKE CONSUMER PRODUCTS, INC.
    Date Cleared
    2007-04-04

    (208 days)

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

    LAKE CONSUMER PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A non-sterile personal lubricant for OTC consumer use, as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide nor does it contain any such component.
    Device Description
    The CVS Personal Lubricant & Moisturizer formula is non-sterile. clear, non- staining, non-greasy, aqueous gel intended for use as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms as demonstrated in condom compatibility testing. This device is not a contraceptive or spermicide, nor does it contain any such component. CVS Personal Lubricant & Moisturizer is packaged in PETE bottles with a foil seal and polypropylene cap.
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