XK-95 HIGH SPEED MOTOR DRILL SYSTEM

XK-95 HIGH SPEED MOTOR DRILL SYSTEM is an FDA 510(k)-cleared medical device (K984035) manufactured by Komet Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 1999. Regulation: 8.