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510(k) Data Aggregation

    K Number
    K230518
    Device Name
    HydraDose Vaginal Suppositories
    Manufacturer
    Date Cleared
    2023-06-23

    (116 days)

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

    MD Labs LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HydraDose Vaginal Suppositories are 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, polyurethane, and polyisoprene condoms.
    Device Description
    HydraDose Vaginal Suppositories is a glyceride-based personal lubricant for over-thecounter use. The subject device is a non-sterile solid preparation containing hyaluronic acid, cocoa butter, triglycerides, and cera alba. The subject device is packaged in sets of five a polyvinyl chloride (PVC)/polyethylene (PE) blister pack. The lubricant is not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms.
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