510(k) K982116

AQUACEL HYDROFIBER WOUND DRESSING by Convatec, A Bristol-Myers Squibb Co. — Product Code KMF

K982116 is an FDA 510(k) premarket notification submitted by Convatec, A Bristol-Myers Squibb Co. for the device "AQUACEL HYDROFIBER WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on September 8, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Convatec, A Bristol-Myers Squibb Co. has at least 9 other 510(k) clearances on record.