510(k) K211440

ASM-301 Level 3 Surgical Mask by American Surgical Mask Company, LLC — Product Code FXX

K211440 is an FDA 510(k) premarket notification submitted by American Surgical Mask Company, LLC for the device "ASM-301 Level 3 Surgical Mask". The FDA issued a decision of Substantially Equivalent on Jun 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.