510(k) K172825

MN-111 by W&H Sterilization S.R.L. — Product Code FLE

K172825 is an FDA 510(k) premarket notification submitted by W&H Sterilization S.R.L. for the device "MN-111". The FDA issued a decision of Substantially Equivalent on May 30, 2018. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. W&H Sterilization S.R.L. has at least 3 other 510(k) clearances on record.