MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT

MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT is an FDA 510(k)-cleared medical device (K091022) 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 11, 2010. Regulation: 8.