510(k) K213598

LUOFUCON Collagen Wound Dressing by Huizhou Foryou Medical Devices Co., Ltd. — Product Code KGN

K213598 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON Collagen Wound Dressing". The FDA issued a decision of Substantially Equivalent on September 20, 2022. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Huizhou Foryou Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.