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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 K082216
Device Name TBD ETHICON MESH
Applicant
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact BRYAN A LISA
Correspondent
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact BRYAN A LISA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/06/2008
Decision Date 09/05/2008
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 No
Predetermined Change
Control Plan Authorized		 No
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