ClearanceBrief
510(k) K080507 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT

ApplicantCeremed , Inc., Los Angeles CA, US
DecisionSubstantially Equivalent, Apr 21, 2008
ReceivedFeb 25, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080507

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.