510(k) K210553

Steam-Dot Process Indicator by Propper Manufacturing Co., Inc. — Product Code JOJ

K210553 is an FDA 510(k) premarket notification submitted by Propper Manufacturing Co., Inc. for the device "Steam-Dot Process Indicator". The FDA issued a decision of Substantially Equivalent on May 19, 2021. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Propper Manufacturing Co., Inc. has at least 6 other 510(k) clearances on record.