510(k) K201732

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On by Dukal Corporation — Product Code FXX

K201732 is an FDA 510(k) premarket notification submitted by Dukal Corporation for the device "Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On". The FDA issued a decision of Substantially Equivalent on February 16, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Dukal Corporation has at least 6 other 510(k) clearances on record.