510(k) K012602

CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX by Crosstex Intl. — Product Code FXX

K012602 is an FDA 510(k) premarket notification submitted by Crosstex Intl. for the device "CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX". The FDA issued a decision of Substantially Equivalent on January 22, 2002. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Crosstex Intl. has at least 1 other 510(k) clearance on record.