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510(k) Data Aggregation

    K Number
    K071483
    Device Name
    TETRIX CREAM
    Date Cleared
    2008-04-04

    (310 days)

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

    CORIA LABORATORIES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tetrix™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix™ Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    Tctrix™ Cream is a non-sterile cream formulation intended for prescription use only. Clinical studies provided evidence that Tetrix™ Cream prevents nickel salts, neomycin and a mixture of fragrances from making contact with the skin.
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