MODEL BT-1 FOT BOLT INSTALLATION KIT

MODEL BT-1 FOT BOLT INSTALLATION KIT is an FDA 510(k)-cleared medical device (K896834) manufactured by Pearl Instruments Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 1990. Regulation: 8.