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 K001122
FOIA Releasable 510(k) K001122
Device Name PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
Applicant
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Applicant Contact GREGORY R JONES
Correspondent
Ethicon, Inc.
P.O Box 151, Route 22 W.
Somerville,  NJ  08876
Correspondent Contact GREGORY R JONES
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/07/2000
Decision Date 05/23/2000
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
-
-