PHOENIX BURR HOLE BUTTON, BURR 1

PHOENIX BURR HOLE BUTTON, BURR 1 is an FDA 510(k)-cleared medical device (K913490) manufactured by Phoenix Bioengineering, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 1992. Regulation: 8.