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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 K103713
Device Name ELTA WOUND CLEANSER
Applicant
Swiss American Products, Inc.
2055 Luna Rd.
Suite 126
Carrollton,  TX  75006
Applicant Contact ERIC LUO
Correspondent
Swiss American Products, Inc.
2055 Luna Rd.
Suite 126
Carrollton,  TX  75006
Correspondent Contact ERIC LUO
Classification Product Code
FRO  
Date Received12/21/2010
Decision Date 06/16/2011
Decision Substantially Equivalent (SESE)
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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