CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT is an FDA 510(k)-cleared medical device (K020205) manufactured by Getinge/Castle, Inc.. 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 June 23, 2002. Regulation: 8.