510(k) K973585

PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR by Propper Mfg. Co., Inc. — Product Code JOJ

K973585 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR". The FDA issued a decision of Substantially Equivalent on November 6, 1998. 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.