510(k) K883827

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

K883827 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "MASKS, VARIOUS TYPES OF SURGICAL MASKS". The FDA issued a decision of Substantially Equivalent on November 17, 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.