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510(k) Data Aggregation
K Number
K132329Device Name
NIVATOPIC PLUS
Manufacturer
Date Cleared
2013-12-20
(147 days)
Product Code
Regulation Number
N/AWhy 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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