510(k) K160988

Biopor, AOC Porous Polyethylene, Cerepor by Ceremed , Inc. — Product Code KKY

K160988 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "Biopor, AOC Porous Polyethylene, Cerepor". The FDA issued a decision of Substantially Equivalent on July 14, 2016. 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.