510(k) K945105 ยท ETB Prosthesis, Partial Ossicular Replacement
POLY/PLATINUM WIRE PISTON
| Applicant | Micromed Development Corp., Clearwater FL, US |
| Decision | Substantially Equivalent, May 14, 1996 |
| Received | Oct 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945105
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.