510(k) K880757

TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD by Tecnol New Jersey Wound Care, Inc. — Product Code FXX

K880757 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD". The FDA issued a decision of Substantially Equivalent on March 11, 1988. 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.