510(k) K151597

Family of Steam Sterilizers B 28 series by Cefla S.C. — Product Code FLE

K151597 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "Family of Steam Sterilizers B 28 series". The FDA issued a decision of Substantially Equivalent on March 4, 2016. 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.