510(k) K211378

LM Surgical Mask Level 3, LM Surgical Mask Level 2, by Liberty Mask, LLC — Product Code FXX

K211378 is an FDA 510(k) premarket notification submitted by Liberty Mask, LLC for the device "LM Surgical Mask Level 3, LM Surgical Mask Level 2,". The FDA issued a decision of Substantially Equivalent on Dec 16, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.