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510(k) Data Aggregation

    K Number
    K200098
    Device Name
    VagiVital Aktivgel
    Manufacturer
    Peptonic Medical AB
    Date Cleared
    2020-11-10

    (299 days)

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

    Peptonic Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VagiVital Aktivgel 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
    Device Description
    VagiVital Aktivgel is a water-based personal lubricant containing water, hypromellose, benzoic acid, lactic acid, and sodium hydroxide. VagiVital Aktivgel is provided in a 36 ml aluminum tube and may be packaged together with a reusable applicator.
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