MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER is an FDA 510(k)-cleared medical device (K990189) manufactured by Midmark Corp.. 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 18, 1999. Regulation: 8.