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510(k) Data Aggregation

    K Number
    K051288
    Device Name
    VIELLE LUBRICANT
    Manufacturer
    CST MEDICAL LIMITED
    Date Cleared
    2006-02-03

    (261 days)

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

    CST MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.
    Device Description
    Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.
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