510(k) K080070 ยท ETB Prosthesis, Partial Ossicular Replacement
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
| Applicant | Grace Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Apr 17, 2008 |
| Received | Jan 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080070
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.