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 Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K133356
Device Name PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Applicant Contact ELLIOTT JANG
Correspondent
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact ELLIOTT JANG
Regulation Number878.5010
Classification Product Code
GAW  
Date Received10/31/2013
Decision Date 12/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-