510(k) K161815 ยท KRH Ring, Annuloplasty
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
| Applicant | Genesee Biomedical, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Oct 12, 2016 |
| Received | Jul 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161815
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.