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510(k) Data Aggregation

    K Number
    K072741
    Device Name
    PRE-VA VAGINAL LUBRICANT
    Manufacturer
    INGFERTILITY, LLC
    Date Cleared
    2008-07-16

    (293 days)

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

    INGFERTILITY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions. - As a personal lubricant Pre-Va supplements the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.
    Device Description
    This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Pre~Va is used to lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. It is also used as a personal lubricant to supplement the body's own natural lubricating fluids and to enhance the comfort of intimate sexual activity. The formulation does not harm sperm function and has a pH and osmolarity that are physiologic ("balanced") to that of fertile cervical mucus and semen. The product is compatible with latex and polyurethane condoms.
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