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510(k) Data Aggregation

    K Number
    K021737
    Device Name
    REPHRESH VAGINAL GEL
    Manufacturer
    COLUMBIA LABORATORIES, INC.
    Date Cleared
    2002-08-26

    (90 days)

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

    COLUMBIA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    May be used as a personal lubricant when vaginal dryness causes discomfort. Also eases insertion of tampons.
    Device Description
    RepHresh™ Vaginal Gel Personal Lubricant
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