510(k) K924935

HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT by Polyclinic Medical Center — Product Code KKY

K924935 is an FDA 510(k) premarket notification submitted by Polyclinic Medical Center for the device "HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT". The FDA issued a decision of Substantially Equivalent on September 2, 1993. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Polyclinic Medical Center has at least 1 other 510(k) clearance on record.