510(k) K161052 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
OsteoFab Patient Specific Facial Device
| Applicant | Oxford Performance Materials, Inc., South Windsor CT, US |
| Decision | Substantially Equivalent, Jul 20, 2016 |
| Received | Apr 14, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161052
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.