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510(k) Data Aggregation

    K Number
    K955648
    Device Name
    K-Y PERSONAL LUBRICANT
    Manufacturer
    ORTHO PHARMACEUTICAL CORP.
    Date Cleared
    1996-06-21

    (192 days)

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

    ORTHO PHARMACEUTICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-Y® Liquid Personal Lubricant is an over-the-counter personal lubricant. This device is indicated to enhance the comfort and ease of intimate activity with or without a latex condom. K-Y ® Liquid Personal Lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourse.
    Device Description
    The K-Y® Liquid Personal Lubricant formula is non-sticky, nonstaining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble clear, high viscosity gel-like liquid. Because it is water-soluble, K-Y® Liquid Personal Lubricant is easily rinsed off with water. The product is packaged in a convenient to use squeeze bottle with a flip-top cap.
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