510(k) K910778

STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) by Mdt Biologic Co. — Product Code FLE

K910778 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)". The FDA issued a decision of Substantially Equivalent on October 28, 1991. 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.