510(k) K180874

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield by 3M Healthcare — Product Code FXX

K180874 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield". The FDA issued a decision of Substantially Equivalent on July 31, 2018. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. 3M Healthcare has at least 10 other 510(k) clearances on record.