510(k) K013764 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
IMMIX BONE GRAFT EXTENDER
| Applicant | Osteogenics Biomedical, Inc., Fort Worth TX, US |
| Decision | Substantially Equivalent, May 16, 2002 |
| Received | Nov 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013764
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.