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, Absorbable, Synthetic
510(k) Number K964072
Device Name MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
Applicant
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Applicant Contact JOHN D PAULSON
Correspondent
Ethicon, Inc.
Route 22 W. P.O. Box 151
Somerville,  NJ  08876 -0151
Correspondent Contact JOHN D PAULSON
Regulation Number878.4830
Classification Product Code
GAN  
Date Received10/11/1996
Decision Date 12/18/1996
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
Recalls CDRH Recalls
-
-