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, Steel, Monofilament And Multifilament, Sterile
510(k) Number K991073
Device Name ACIER SUTURES
Applicant
CARDIO THORACIC SYSTEMS
10600 N. TANTAU AVE.
CUPERTINO,  CA  95014 -0739
Applicant Contact MICHAEL J BILLIG
Correspondent
CARDIO THORACIC SYSTEMS
10600 N. TANTAU AVE.
CUPERTINO,  CA  95014 -0739
Correspondent Contact MICHAEL J BILLIG
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received03/31/1999
Decision Date 07/30/1999
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
-
-