510(k) K072113

INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 by Integra Lifesciences Corp. — Product Code KGN

K072113 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301". The FDA issued a decision of Substantially Equivalent on October 10, 2007. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.