510(k) K852114

ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 by Ars Enterprises, Inc. — Product Code FLE

K852114 is an FDA 510(k) premarket notification submitted by Ars Enterprises, Inc. for the device "ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000". The FDA issued a decision of Substantially Equivalent on September 27, 1985. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Ars Enterprises, Inc. has at least 3 other 510(k) clearances on record.