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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K943339
Device Name GAUZE SPONGE (E.W.A. LTD./VARIOUS)
Applicant
E.W.A., Ltd.
35 Beaverson Blvd. Bldg. 8c
Brick,  NJ  08723
Applicant Contact FRANK WELLS
Correspondent
E.W.A., Ltd.
35 Beaverson Blvd. Bldg. 8c
Brick,  NJ  08723
Correspondent Contact FRANK WELLS
Classification Product Code
EFQ  
Date Received07/12/1994
Decision Date 08/23/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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