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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 K061533
FOIA Releasable 510(k) K061533
Device Name PROCEED VENTRAL PATCH
Applicant
ETHICON, INC.
RT. 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876
Applicant Contact BRYAN A LISA
Correspondent
ETHICON, INC.
RT. 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876
Correspondent Contact BRYAN A LISA
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/02/2006
Decision Date 12/11/2006
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
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