510(k) K191819

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border by Winner Medical Co., Ltd. — Product Code FRO

K191819 is an FDA 510(k) premarket notification submitted by Winner Medical Co., Ltd. for the device "Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border". The FDA issued a decision of Substantially Equivalent on May 14, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Winner Medical Co., Ltd. has at least 10 other 510(k) clearances on record.