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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 K031925
Device Name PROCEED TRILAMINATE SURGICAL MESH
Applicant
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact REY LIBROJO
Correspondent
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact REY LIBROJO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/23/2003
Decision Date 09/17/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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