GAMMA RADIATION STERILIZATION PRECEDURE

GAMMA RADIATION STERILIZATION PRECEDURE is an FDA 510(k)-cleared medical device (K781668) manufactured by Cutter Laboratories, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 2, 1978. Regulation: 8.