510(k) K110554 ยท HPZ Implant, Eye Sphere
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
| Applicant | Ceramisys, Ltd., Centercille MA, US |
| Decision | Substantially Equivalent, Nov 2, 2011 |
| Received | Feb 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110554
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.