510(k) K915445 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
MAALEABLE FACIAL IMPLANT
| Applicant | Biomet Ussc Orthopedics, Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 3, 1992 |
| Received | Dec 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915445
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.