510(k) K970375 ยท KRH Ring, Annuloplasty
ANNULOFLO SYSTEM
| Applicant | Carbomedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jul 25, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970375
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.