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510(k) Data Aggregation

    K Number
    K152918
    Device Name
    Gun Oil, Pink, Gun Oil H2O, Pink Water
    Manufacturer
    EMPOWERED PRODUCTS, INC.
    Date Cleared
    2016-06-02

    (244 days)

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

    EMPOWERED PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gun Oil silicone lubricant is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms. Pink silicone lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyurethane condoms. This product is not compatible with polyisoprene or natural rubber latex condoms. Gun Oil H20 water-based is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms. Pink Water water-based lubricant for women is a personal lubricant intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. This product is compatible with polyisoprene condoms. This product is not compatible with polyurethane or natural rubber latex condoms.
    Device Description
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