510(k) K021161

TSO3 OZONE CHEMICAL INDICATOR by Technologies of Sterilization With Oxone, Tso3, Inc. — Product Code JOJ

K021161 is an FDA 510(k) premarket notification submitted by Technologies of Sterilization With Oxone, Tso3, Inc. for the device "TSO3 OZONE CHEMICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on August 27, 2003. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Technologies of Sterilization With Oxone, Tso3, Inc. has at least 1 other 510(k) clearance on record.