510(k) K111453

STEAM DOT BLU PROCESS INDICATOR by Propper Mfg. Co., Inc. — Product Code JOJ

K111453 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "STEAM DOT BLU PROCESS INDICATOR". The FDA issued a decision of Substantially Equivalent on April 5, 2012. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Propper Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.