SYSTEM 1.5 STERILE PROCESSING SYSTEM

SYSTEM 1.5 STERILE PROCESSING SYSTEM is an FDA 510(k)-cleared medical device (K090036) manufactured by STERIS Corporation. 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 4, 2010. Regulation: 8.