510(k) K100846

IMC SURGICAL FACE MASK by International Medsurg Connection — Product Code FXX

K100846 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "IMC SURGICAL FACE MASK". The FDA issued a decision of Substantially Equivalent on August 16, 2010. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. International Medsurg Connection has at least 10 other 510(k) clearances on record.