510(k) K083683 ยท KRH Ring, Annuloplasty
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Feb 25, 2009 |
| Received | Dec 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083683
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.