510(k) K083650

EMU-GRAPH 4 EMULATOR, MODEL CI 144 by Steritec Products, Inc. — Product Code JOJ

K083650 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "EMU-GRAPH 4 EMULATOR, MODEL CI 144". The FDA issued a decision of Substantially Equivalent on March 5, 2009. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products, Inc. has at least 10 other 510(k) clearances on record.