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 K945701
Device Name SURGILENE(R) SUTURES
Applicant
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Applicant Contact STEVE TAMSETT
Correspondent
DAVIS & GECK, INC.
AMERICAN CYNAMID COMPANY
ONE CASPER STREET
DANBURY,  CT  06810
Correspondent Contact STEVE TAMSETT
Regulation Number878.5010
Classification Product Code
GAW  
Date Received11/09/1994
Decision Date 01/24/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-