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510(k) Data Aggregation

    K Number
    K012203
    Device Name
    CLAY-PARK LABS, INC. - LUBRICATING JELLY
    Manufacturer
    CLAY-PARK LABS, INC.
    Date Cleared
    2001-08-27

    (45 days)

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

    CLAY-PARK LABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Clay-Park Labs Lubricating Jelly is intended for personal lubrication when vaginal dryness causes discomfort and as a lubricant for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.
    Device Description
    The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle of glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
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