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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,Nonresorbable For External Use
510(k) Number K923378
Device Name USP TYPE VII GAUZE SPONGES
Applicant
E.W.A., Ltd.
164 Flint Rock Dr.
Lakewood,  NJ  08701
Applicant Contact WELLS, JR.
Correspondent
E.W.A., Ltd.
164 Flint Rock Dr.
Lakewood,  NJ  08701
Correspondent Contact WELLS, JR.
Regulation Number878.4014
Classification Product Code
NAB  
Date Received07/09/1992
Decision Date 10/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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