510(k) K140437 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
SU-POR SURGICAL IMPLANT
| Applicant | Poriferous, LLC, Newnan GA, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Feb 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140437
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.