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510(k) Data Aggregation

    K Number
    K211967
    Device Name
    Sensual Massage, Ultra Pure
    Manufacturer
    Dreambrands, Inc.
    Date Cleared
    2021-11-09

    (138 days)

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

    Dreambrands, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sensual Massage/Ultra Pure 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 rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant comprised on dimethoconol, dimethicone, and cyclopentasiloxane. This over-thecounter product is formulated to be clear, non-greasy, and odorless. The Sensual Massage/Ultra Pure lubricant is neither a contraceptive nor a spermicide.
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