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510(k) Data Aggregation

    K Number
    K051688
    Device Name
    FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
    Manufacturer
    TRIMENSA PHARMACEUTICALS
    Date Cleared
    2006-07-12

    (384 days)

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

    TRIMENSA PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ForPlay, SLIP and PrePair personal Lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of diagnostic or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are recommended as personal lubricants and are principally intended to supplement the body's natural lubrication, to moisturize and enhance the comfort and ease of intimacy with or without a condom.
    Device Description
    "ForPlay, SLIP and PrePair Personal Lubricants" are colorless, odorless, non-sticky, non-greasy, nonirritating water based lubricants. They are water-soluble, high viscosity gels and liquids. Because they are water-soluble, ForPlay, SLIP and PrePair Personal Lubricants are easily rinsed off with water leaving NO residue.
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