510(k) K021504

TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 by Tuttnauer U.S.A Co, Ltd. — Product Code FLE

K021504 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540". The FDA issued a decision of Substantially Equivalent on July 25, 2002. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Tuttnauer U.S.A Co, Ltd. has at least 8 other 510(k) clearances on record.