510(k) K964358

AMSEAL SURGICAL FACE MASK by American Seal Co. — Product Code FXX

K964358 is an FDA 510(k) premarket notification submitted by American Seal Co. for the device "AMSEAL SURGICAL FACE MASK". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. American Seal Co. has at least 5 other 510(k) clearances on record.