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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K161726
Device Name E-Pack Procedure Kit
Applicant
ETHICON, INC.
ROUTE 22 WM P.O. BOX 151
SOMERVILLE,  NJ  08876
Applicant Contact ENZA DESERIO
Correspondent
ETHICON, INC.
ROUTE 22 WM P.O. BOX 151
SOMERVILLE,  NJ  08876
Correspondent Contact ENZA DESERIO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received06/22/2016
Decision Date 07/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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