510(k) K883828

CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS by Greene International Corp. — Product Code FXX

K883828 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS". The FDA issued a decision of Substantially Equivalent on October 3, 1988. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Greene International Corp. has at least 7 other 510(k) clearances on record.