510(k) K143287

Fluidshield* Surgical Mask with Expanded Chamber by Halyard Health, Inc. — Product Code FXX

K143287 is an FDA 510(k) premarket notification submitted by Halyard Health, Inc. for the device "Fluidshield* Surgical Mask with Expanded Chamber". The FDA issued a decision of Substantially Equivalent on March 24, 2015. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Halyard Health, Inc. has at least 10 other 510(k) clearances on record.