510(k) K090428 ยท KRH Ring, Annuloplasty
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, May 7, 2009 |
| Received | Feb 19, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090428
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.