510(k) K191670

CureOs TCP by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic — Product Code MQV

K191670 is an FDA 510(k) premarket notification submitted by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic for the device "CureOs TCP". The FDA issued a decision of Substantially Equivalent on Aug 4, 2020. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.