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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 K060713
Device Name PROCEED SURGICAL MESH
Applicant
ETHICON INC.
ROUTE 22 WEST
PO BOX 151
SOMERVILLE,  NJ  08876
Applicant Contact SERGIO J GADALETA
Correspondent
ETHICON INC.
ROUTE 22 WEST
PO BOX 151
SOMERVILLE,  NJ  08876
Correspondent Contact SERGIO J GADALETA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/17/2006
Decision Date 05/25/2006
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
Recalls CDRH Recalls
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