510(k) K896193

TECNOL LAZER(TM) SURGICAL MASK by Tecnol New Jersey Wound Care, Inc. — Product Code FXX

K896193 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL LAZER(TM) SURGICAL MASK". The FDA issued a decision of Substantially Equivalent on February 27, 1990. 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.