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, Polyethylene
510(k) Number K930591
Device Name TI-CRON AND DACRON SUTURES
Applicant
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Applicant Contact JOHN SCHAEFER
Correspondent
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Correspondent Contact JOHN SCHAEFER
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/04/1993
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-