ELTA WOUND CLEANSER


Device Classification Name

dressing, wound, drug

510(k) Number K103713
Device Name ELTA WOUND CLEANSER
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

Correspodent Contact eric luo
Classification Product Code
FRO  
Date Received 12/21/2010
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