510(k) K870056

TECNOL CLASSIC CONE MASK by Tecnol New Jersey Wound Care, Inc. — Product Code FXX

K870056 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL CLASSIC CONE MASK". The FDA issued a decision of Substantially Equivalent on February 6, 1987. 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.