510(k) K982547

STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR by Steritec Products Mfg Co, Inc. — Product Code JOJ

K982547 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR". The FDA issued a decision of Substantially Equivalent on Oct 8, 1998. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products Mfg Co, Inc. has at least 10 other 510(k) clearances on record.