510(k) K190506 ยท KRH Ring, Annuloplasty
NeoForm Annuloplasty Ring
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Apr 18, 2019 |
| Received | Mar 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190506
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.