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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 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact SERGIO J GADALETA
Correspondent
Ethicon, Inc.
Route 22 W.
P.O. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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