510(k) K934861 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
HARD TISSUE REPLACEMENT (HTR) GRANULAR
| Applicant | Poly-Medics,Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 4, 1994 |
| Received | Oct 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934861
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.