510(k) K221218

Silverlon Wound Contact, Burn Contact Dressings by Argentum Medical, Inc. — Product Code FRO

K221218 is an FDA 510(k) premarket notification submitted by Argentum Medical, Inc. for the device "Silverlon Wound Contact, Burn Contact Dressings". The FDA issued a decision of Substantially Equivalent on October 26, 2022. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum Medical, Inc. has at least 9 other 510(k) clearances on record.