K241225 is an FDA 510(k) clearance for the Silverlon® Wound Contact, Burn Contact Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Argentum Medical, LLC (Geneva, US). The FDA issued a Cleared decision on July 31, 2024, 90 days after receiving the submission on May 2, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K241225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2024 |
| Decision Date | July 31, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |