510(k) K972815 ยท ETB Prosthesis, Partial Ossicular Replacement
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
| Applicant | Grace Medical, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, Oct 8, 1997 |
| Received | Jul 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972815
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.