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510(k) Data Aggregation

    K Number
    K133336
    Device Name
    PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
    Manufacturer
    PJUR GROUP,LUXEMBOURG S.A.
    Date Cleared
    2014-07-24

    (268 days)

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

    PJUR GROUP,LUXEMBOURG S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide are personal lubricants, for genital area application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural latex, polyurethane, and polyisoprene condoms.
    Device Description
    The pjur® family of silicone based lubricants are non-sterile, silicone-based personal lubricants. These over-the-counter products are formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® family of silicone based lubricants contains neither a contraceptive nor a spermicide.
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