510(k) K061716

PRESTIGE AMERITECH FACE MASK by Prestige Ameritech — Product Code FXX

K061716 is an FDA 510(k) premarket notification submitted by Prestige Ameritech for the device "PRESTIGE AMERITECH FACE MASK". The FDA issued a decision of Substantially Equivalent on August 14, 2006. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Prestige Ameritech has at least 5 other 510(k) clearances on record.