510(k) K211773

Single-use Surgical Mask by Taiwan Seafood and Fish Corporation — Product Code FXX

K211773 is an FDA 510(k) premarket notification submitted by Taiwan Seafood and Fish Corporation for the device "Single-use Surgical Mask". The FDA issued a decision of Substantially Equivalent on December 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.