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 K093903
Device Name ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
Applicant
Genesee Biomedical, Inc.
1308 S. Jason St.
Denver,  CO  80223
Applicant Contact JOHN T.M. WRIGHT
Correspondent
Genesee Biomedical, Inc.
1308 S. Jason St.
Denver,  CO  80223
Correspondent Contact JOHN T.M. WRIGHT
Regulation Number870.3800
Classification Product Code
KRH  
Date Received12/22/2009
Decision Date 07/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-