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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 K180829
Device Name PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
Applicant
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Applicant Contact Stephanie Saati
Correspondent
Ethicon, Inc.
Route 22 W.
P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact Stephanie Saati
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/30/2018
Decision Date 06/28/2018
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
Predetermined Change
Control Plan Authorized		 No
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