510(k) K171645

CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle by Strukmyer Medical — Product Code KGN

K171645 is an FDA 510(k) premarket notification submitted by Strukmyer Medical for the device "CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle". The FDA issued a decision of Substantially Equivalent on July 25, 2017. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Strukmyer Medical has at least 2 other 510(k) clearances on record.