510(k) K190005

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer by Sterilucent, Inc. — Product Code MLR

K190005 is an FDA 510(k) premarket notification submitted by Sterilucent, Inc. for the device "Sterilucent HC 80TT Hydrogen Peroxide Sterilizer". The FDA issued a decision of Substantially Equivalent on September 13, 2019. 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.