510(k) K911907

FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS by Tecnol New Jersey Wound Care, Inc. — Product Code FXX

K911907 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS". The FDA issued a decision of Substantially Equivalent on July 8, 1991. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.