510(k) K031353

SOLUTION FACE MASKS by A Plus International, Inc. — Product Code FXX

K031353 is an FDA 510(k) premarket notification submitted by A Plus International, Inc. for the device "SOLUTION FACE MASKS". The FDA issued a decision of Substantially Equivalent on June 19, 2003. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. A Plus International, Inc. has at least 10 other 510(k) clearances on record.