510(k) K813078

CONTURA DISPOS. SURG. FACE MASK by American Convertors Div., American Pharmaseal — Product Code FXX

K813078 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "CONTURA DISPOS. SURG. FACE MASK". The FDA issued a decision of Substantially Equivalent on December 18, 1981. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.