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510(k) Data Aggregation

    K Number
    K193444
    Device Name
    Vagisan MoistCream Cremolum
    Date Cleared
    2020-12-04

    (358 days)

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

    **Dr. August Wolff GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Vagisan MoistCream Cremolum is a personal lubricant, a suppository for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
    Device Description
    The Vagisan MoistCream Cremolum is a ready-to-use, non-sterile, glycerin-based personal lubricant suppository for intravaginal application that melts after digital insertion to form a smooth cream. The device is intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Vagisan MoistCream Cremolum consists of hydrogenated coco-glycerides, ceteary1 alcohol, lactic acid, calcium lactate, PEG-20 glyceryl stearate, and sodium carbomer. Each vaginal suppository is individually packaged in a foil blister pack, which are sold in boxes of eight or 16 vaginal suppositories.
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    K Number
    K152507
    Device Name
    Dr. Wolff Vagisan Moisturising Cream
    Date Cleared
    2016-05-20

    (261 days)

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

    **DR. AUGUST WOLFF GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Vagisan® Moisturizing Cream is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
    Device Description
    Vagisan Moisturizing Cream is a non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream delivered in a tube with a reusable applicator or sachet (sample size) as a long-lasting moisturizer for vaginal dryness.
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