510(k) K083342 ยท HPZ Implant, Eye Sphere
ORBITAL RECONSTRUCTIVE IMPLANT II
| Applicant | Evera Medical, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Mar 12, 2009 |
| Received | Nov 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083342
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.