SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM is an FDA 510(k)-cleared medical device (K102462) 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 September 20, 2010. Regulation: 8.