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 K090428
Device Name ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
Applicant
Genesee Biomedical, Inc.
1308 S. Jason St.
Denver,  CO  80223
Applicant Contact JOHN WRIGHT
Correspondent
Genesee Biomedical, Inc.
1308 S. Jason St.
Denver,  CO  80223
Correspondent Contact JOHN WRIGHT
Regulation Number870.3800
Classification Product Code
KRH  
Date Received02/19/2009
Decision Date 05/07/2009
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
-
-