510(k) K210063

Freudenberg Surgical Mask by Freudenberg Performance Materials LP — Product Code FXX

K210063 is an FDA 510(k) premarket notification submitted by Freudenberg Performance Materials LP for the device "Freudenberg Surgical Mask". The FDA issued a decision of Substantially Equivalent on Feb 5, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.