510(k) K022816

W & H LISA STEAM STERILIZER by A-Dec, Inc. — Product Code FLE

K022816 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "W & H LISA STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on February 7, 2003. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. A-Dec, Inc. has at least 10 other 510(k) clearances on record.