510(k) K202607

Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs by String King Lacrosse, LLC — Product Code FXX

K202607 is an FDA 510(k) premarket notification submitted by String King Lacrosse, LLC for the device "Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs". The FDA issued a decision of Substantially Equivalent on April 23, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. String King Lacrosse, LLC has at least 1 other 510(k) clearance on record.