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 Ring, Annuloplasty
510(k) Number K023185
Device Name ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
Applicant
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact TEFFANY HANKINSON
Correspondent
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact TEFFANY HANKINSON
Regulation Number870.3800
Classification Product Code
KRH  
Date Received09/24/2002
Decision Date 12/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-