510(k) K201182

iMask Disposable Surgical Face Mask by Pac-Dent, Inc. — Product Code FXX

K201182 is an FDA 510(k) premarket notification submitted by Pac-Dent, Inc. for the device "iMask Disposable Surgical Face Mask". The FDA issued a decision of Substantially Equivalent on February 19, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Pac-Dent, Inc. has at least 7 other 510(k) clearances on record.