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510(k) Data Aggregation
K Number
K071483Device Name
TETRIX CREAM
Manufacturer
Date Cleared
2008-04-04
(310 days)
Product Code
Regulation Number
N/AWhy 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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