510(k) K022854

ACELL UBM HYDRATED WOUND DRESSING by Acell, Inc. — Product Code KGN

K022854 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "ACELL UBM HYDRATED WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on December 30, 2002. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Acell, Inc. has at least 10 other 510(k) clearances on record.