510(k) K133809 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
| Applicant | Oxford Performance Materials, South Windsor CT, US |
| Decision | Substantially Equivalent, Jul 28, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133809
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.