510(k) K023400 ยท HPZ Implant, Eye Sphere
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
| Applicant | Fci Ophthalmics, Inc., Centercille MA, US |
| Decision | Substantially Equivalent, Aug 22, 2003 |
| Received | Oct 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023400
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.