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510(k) Data Aggregation

    K Number
    K092297
    Device Name
    ELETONE CREAM
    Manufacturer
    FERNDALE PHARMA GROUP, INC.
    Date Cleared
    2009-10-09

    (72 days)

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

    FERNDALE PHARMA GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).
    Device Description
    Eletone® Cream is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 100g plastic tubes.
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