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510(k) Data Aggregation

    K Number
    K190752
    Device Name
    Satisfaite
    Date Cleared
    2019-12-13

    (263 days)

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

    FemmePharma Consumer Healthcare, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Satisfaite™ is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to supplement the body's natural lubrication, and to enhance the ease and comfort of intimate sexual activity. This product is compatible with natural rubber, latex, and polyisoprene condoms; and is not compatible with polyurethane condoms.
    Device Description
    Satisfaite™ is a topically applied, water-based personal lubricant for vaginal application, intended to moisturize and lubricate, and to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Satisfaite™ is self-administered to the user via a prefilled unit dose applicator for intravaginal administration. The device consists of the polypropylene plastic applicator pre-filled with the lubricant. The three main ingredients of the lubricant by percent weight are purified water, glycerin and propylene glycol. Each pre-filled applicator holds 1 gram of lubricant and is for a single use in a home environment. Each pre-filled applicator is individually over-wrapped with a disposable polypropylene sleeve and packaged 10 units to a cardboard box. The lubricant makes direct patient contact with the vaginal mucosa and has a contact duration of < 24 hours. The applicator also makes direct patient contact with the vaginal mucosa only at the time of application and is discarded after use.
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