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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 K172089
Device Name PROLENE Soft Polypropylene Mesh
Applicant
Ethicon, Inc.
Route 22 West, P.O. Box 151
Somerville,  NJ  08876 -0151
Applicant Contact Stephanie Saati
Correspondent
Ethicon, Inc.
Route 22 West, P.O. Box 151
Somerville,  NJ  08876 -0151
Correspondent Contact Stephanie Saati
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/11/2017
Decision Date 10/05/2017
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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