510(k) K880613

ACCO(R) FACE MASK by Absorbent Cotton Co., Inc. — Product Code FXX

K880613 is an FDA 510(k) premarket notification submitted by Absorbent Cotton Co., Inc. for the device "ACCO(R) FACE MASK". The FDA issued a decision of Substantially Equivalent on March 4, 1988. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Absorbent Cotton Co., Inc. has at least 9 other 510(k) clearances on record.