510(k) K043133 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
| Applicant | Ceremed , Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 2, 2005 |
| Received | Nov 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043133
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.