510(k) K991394 ยท ETB Prosthesis, Partial Ossicular Replacement
STAPES PROSTHESES
| Applicant | Grace Medical, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, May 18, 1999 |
| Received | Apr 21, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991394
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.