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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 K141560
Device Name ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
Applicant
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
somerville,  NJ  08876 -0151
Applicant Contact susan lin
Correspondent
ETHICON, INC.
P.O. BOX 151
ROUTE 22 WEST
somerville,  NJ  08876 -0151
Correspondent Contact susan lin
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/12/2014
Decision Date 10/23/2014
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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