510(k) K143311

Pre-vacuum Tabletop Autoclave by Tuttnauer U.S.A Co, Ltd. — Product Code FLE

K143311 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "Pre-vacuum Tabletop Autoclave". The FDA issued a decision of Substantially Equivalent on January 15, 2015. 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.