BLUE SEAL II STERILIZATION POUCH

BLUE SEAL II STERILIZATION POUCH is an FDA 510(k)-cleared medical device (K851340) manufactured by American Sterilizer Co.. 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 23, 1985. Regulation: 8.