510(k) K152033

Cook ECM Powder by Cook Biotech Incorporated — Product Code KGN

K152033 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Cook ECM Powder". The FDA issued a decision of Substantially Equivalent on August 19, 2015. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.