510(k) K911322

MODEL #M9 ULTRACLAVE STEAM STERILIZER by Midmark Corp. — Product Code FLE

K911322 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MODEL #M9 ULTRACLAVE STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on August 26, 1991. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Midmark Corp. has at least 10 other 510(k) clearances on record.