510(k) K160022

LUOFUCON Silicone Ag foam dressing by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K160022 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON Silicone Ag foam dressing". The FDA issued a decision of Substantially Equivalent on August 17, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Huizhou Foryou Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.