Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-