510(k) K894205

TECNOL SILK STRIP by Tecnol New Jersey Wound Care, Inc. — Product Code FPX

K894205 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL SILK STRIP". The FDA issued a decision of Substantially Equivalent on July 25, 1989. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.