510(k) K231719

Medical Surgical Mask by Azur Medical Company, Inc. — Product Code FXX

K231719 is an FDA 510(k) premarket notification submitted by Azur Medical Company, Inc. for the device "Medical Surgical Mask". The FDA issued a decision of Substantially Equivalent on March 19, 2024. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Azur Medical Company, Inc. has at least 3 other 510(k) clearances on record.