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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K092712
Device Name SKIN BARRIER FILM
Applicant
Lodestar Products, Inc.
6833 Saint Lawrence St.
Plano,  TX  75024
Applicant Contact ERIC LUO
Correspondent
Lodestar Products, Inc.
6833 Saint Lawrence St.
Plano,  TX  75024
Correspondent Contact ERIC LUO
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/03/2009
Decision Date 02/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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