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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K071703
Device Name ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
Applicant
SWISS AMERICAN PRODUCTS, INC.
2055 LUNA RD., STE. 126
CARROLLTON,  TX  75006
Applicant Contact ERIC LUO
Correspondent
SWISS AMERICAN PRODUCTS, INC.
2055 LUNA RD., STE. 126
CARROLLTON,  TX  75006
Correspondent Contact ERIC LUO
Classification Product Code
FRO  
Date Received06/21/2007
Decision Date 08/22/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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