510(k) K161848

Family of Steam sterilizers B17 B22 Series by Cefla S.C. — Product Code FLE

K161848 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "Family of Steam sterilizers B17 B22 Series". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Cefla S.C. has at least 10 other 510(k) clearances on record.