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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 K163152
Device Name PROLENE Soft Polypropylene Mesh
Applicant
Ethicon, Inc.
Route 22 West, P.O. Box 151
Somerville,  NJ  08876
Applicant Contact Debbie Fazen
Correspondent
Ethicon, Inc.
Route 22 West, P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact Debbie Fazen
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/10/2016
Decision Date 03/11/2017
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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