BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP

BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP is an FDA 510(k)-cleared medical device (K993871) manufactured by Allegiance Healthcare Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2000. Regulation: 8.