510(k) K092012

PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 by Primed Medical Products, Inc. — Product Code FXX

K092012 is an FDA 510(k) premarket notification submitted by Primed Medical Products, Inc. for the device "PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70". The FDA issued a decision of Substantially Equivalent on September 25, 2009. 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 9 other 510(k) clearances on record.