510(k) K910777

MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER by Mdt Biologic Co. — Product Code FLE

K910777 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on March 27, 1992. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.