510(k) K984035

XK-95 HIGH SPEED MOTOR DRILL SYSTEM by Komet Medical — Product Code HBE

K984035 is an FDA 510(k) premarket notification submitted by Komet Medical for the device "XK-95 HIGH SPEED MOTOR DRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 3, 1999. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Komet Medical has at least 2 other 510(k) clearances on record.