510(k) K140464

STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER by Sterilucent, Inc. — Product Code MLR

K140464 is an FDA 510(k) premarket notification submitted by Sterilucent, Inc. for the device "STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER". The FDA issued a decision of Substantially Equivalent on October 31, 2014. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Sterilucent, Inc. has at least 6 other 510(k) clearances on record.