CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)

CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) is an FDA 510(k)-cleared medical device (K970907) 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 November 11, 1997. Regulation: 8.