510(k) K031152

PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) by Propper Mfg. Co., Inc. — Product Code JOJ

K031152 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)". The FDA issued a decision of Substantially Equivalent on August 17, 2004. 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.