510(k) K230679 ยท KRH Ring, Annuloplasty
WellsForm Tricuspid Annuloplasty Band (WF)
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Mar 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230679
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.