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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 K181268
Device Name PROLENE (Polypropylene) 3D Patch
Applicant
Ethicon, Inc.
Route 22 West
P.O Box 151
somerville,  NJ  08876 -0151
Applicant Contact melina escobar
Correspondent
Ethicon, Inc.
Route 22 West
P.O Box 151
somerville,  NJ  08876 -0151
Correspondent Contact melina escobar
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/14/2018
Decision Date 07/26/2018
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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