510(k) K943654

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS by Mdt Biologic Co. — Product Code MLR

K943654 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS". The FDA issued a decision of Substantially Equivalent on August 2, 1995. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.