510(k) K981045 ยท ETB Prosthesis, Partial Ossicular Replacement
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
| Applicant | Exmoor Plastics , Ltd., Taunton, GB |
| Decision | Substantially Equivalent, May 20, 1998 |
| Received | Mar 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981045
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.