MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR

MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR is an FDA 510(k)-cleared medical device (K071014) manufactured by Advanced Sterilization Products. 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 May 23, 2007. Regulation: 8.