510(k) K061711

OASIS WOUND MATRIX by Cook Biotech, Inc. — Product Code KGN

K061711 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "OASIS WOUND MATRIX". The FDA issued a decision of Substantially Equivalent on July 19, 2006. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.