SUPRASHIELD EXPRESS STERILIZATION WRAP

SUPRASHIELD EXPRESS STERILIZATION WRAP is an FDA 510(k)-cleared medical device (K990300) 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 February 9, 1999. Regulation: 8.