510(k) K973550

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

K973550 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "TUTTNAUER TABLE-TOP AUTOCLAVE". The FDA issued a decision of Substantially Equivalent on October 29, 1997. 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.