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510(k) Data Aggregation
K Number
K092712Device Name
SKIN BARRIER FILM
Manufacturer
LODESTAR PRODUCTS, INC.
Date Cleared
2010-02-23
(173 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
LODESTAR PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Skin Barrier Film is a liquid intended for use as a film-forming product. Upon application to intact or damaged skin, this product forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction. It is intended as a primary barrier against irritation from body fluids.
Device Description
Skin Barrier Film is a liquid intended for use as a film-forming product.
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