510(k) K974365 ยท ETB Prosthesis, Partial Ossicular Replacement
MILLS INCUS HA SLEEVE
| Applicant | Exmoor Plastics , Ltd., Taunton, GB |
| Decision | Substantially Equivalent, Jan 22, 1998 |
| Received | Nov 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974365
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.