510(k) K771229

STERILIZERS, 3100 SERIES TRIM LINE by Castle Co. — Product Code FLE

K771229 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "STERILIZERS, 3100 SERIES TRIM LINE". The FDA issued a decision of Substantially Equivalent on August 2, 1977. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Castle Co. has at least 10 other 510(k) clearances on record.