510(k) K770682

STERILIZER, SERIES 3000, MODIFICATION TO by Castle Co. — Product Code FLE

K770682 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "STERILIZER, SERIES 3000, MODIFICATION TO". The FDA issued a decision of Substantially Equivalent on May 20, 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.