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510(k) Data Aggregation

    K Number
    K132329
    Device Name
    NIVATOPIC PLUS
    Date Cleared
    2013-12-20

    (147 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIVAGEN PHARMACEUTICALS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rx: Nivatopic™ Plus is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Nivatopic™ Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
    Device Description
    Nivatopic Plus is a non-sterile, steroid free, semi-viscous emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.
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