510(k) K081633

PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS by Primed Medical Products, Inc. — Product Code FXX

K081633 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS". The FDA issued a decision of Substantially Equivalent on August 11, 2008. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Primed Medical Products, Inc. has at least 7 other 510(k) clearances on record.