510(k) K113520

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM by STERIS Corporation — Product Code MED

K113520 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 21, 2012. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. STERIS Corporation has at least 10 other 510(k) clearances on record.