510(k) K141009

FORT DEFIANCE AUTOMATED STEAM STERILIZER by Fort Defiance Industries, Inc. — Product Code FLE

K141009 is an FDA 510(k) premarket notification submitted by Fort Defiance Industries, Inc. for the device "FORT DEFIANCE AUTOMATED STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on December 16, 2014. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Fort Defiance Industries, Inc. has at least 2 other 510(k) clearances on record.