510(k) K944588

STERILE PLASTIC DRESSING by Smith & Nephew, Inc. — Product Code KGX

K944588 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "STERILE PLASTIC DRESSING". The FDA issued a decision of Substantially Equivalent on November 7, 1994. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.