510(k) K993856

TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP by Tuttnauer U.S.A Co, Ltd. — Product Code FLE

K993856 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP". The FDA issued a decision of Substantially Equivalent on February 9, 2001. 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.