510(k) K043133

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR by Ceremed , Inc. — Product Code KKY

K043133 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR". The FDA issued a decision of Substantially Equivalent on March 2, 2005. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Ceremed , Inc. has at least 10 other 510(k) clearances on record.