510(k) K070407

DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE by Dukal Corp. — Product Code FXX

K070407 is an FDA 510(k) premarket notification submitted by Dukal Corp. for the device "DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE". The FDA issued a decision of Substantially Equivalent on March 26, 2007. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Dukal Corp. has at least 10 other 510(k) clearances on record.