510(k) K241225

Silverlon® Wound Contact, Burn Contact Dressing by Argentum Medical, LLC — Product Code FRO

K241225 is an FDA 510(k) premarket notification submitted by Argentum Medical, LLC for the device "Silverlon® Wound Contact, Burn Contact Dressing". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum Medical, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2024
Date Received
May 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type