510(k) K831949 ยท KRH Ring, Annuloplasty
PROSTHETIC RINGS #4400 MITRAL & 4500
| Applicant | American Edwards Laboratories, Walker MI, US |
| Decision | Substantially Equivalent - Subject to Tracking & PMS, Jul 29, 1983 |
| Received | Jun 16, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831949
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.