510(k) K170077

LUOFUCON Silicone Ag Foam Dressing with Border by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K170077 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON Silicone Ag Foam Dressing with Border". The FDA issued a decision of Substantially Equivalent on Mar 30, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Huizhou Foryou Medical Devices Co., Ltd. has 22 other 510(k) clearances on record.