510(k) K982597

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE by Johnson & Johnson Medical, Inc. — Product Code KGN

K982597 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE". The FDA issued a decision of Substantially Equivalent on August 20, 1998. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.