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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K051701
Device Name VICRYL * MESH BAG
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Applicant Contact JENNIFER PAINE
Correspondent
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876
Correspondent Contact JENNIFER PAINE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/24/2005
Decision Date 09/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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