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510(k) Data Aggregation

    K Number
    K161385
    Device Name
    Just Like Me Personal Lubricant
    Date Cleared
    2016-08-17

    (90 days)

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

    WTFN-dba Classic Erotica/Holiday Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Just like Personal Lubricant is a personal lubricant, for penile and/or 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 natural latex, polyisoprene, and polyurethane condoms.
    Device Description
    The Just Like Me Personal Lubricant is a non-sterile, water based, over-the- counter personal lubricant formulated to be a clear, non-irritating, non-greasy, odorless liquid. The proposed device contains a blend of ingredients similar to ingredients found in the predicate device. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, and polyurethane condoms during intimate sexual activity as evidenced by condom compatibility testing.
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