510(k) K111402

KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL by Kimberly-Clark — Product Code FXX

K111402 is an FDA 510(k) premarket notification submitted by Kimberly-Clark for the device "KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL". The FDA issued a decision of Substantially Equivalent on October 20, 2011. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Kimberly-Clark has at least 10 other 510(k) clearances on record.