510(k) K963899 ยท ETA Replacement, Ossicular Prosthesis, Total
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
| Applicant | Exmoor Plastics , Ltd., Taunton, GB |
| Decision | Substantially Equivalent, Aug 22, 1997 |
| Received | Sep 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963899
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.