K180570 is an FDA 510(k) clearance for the Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing). This device is classified as a Dressing, Wound, Drug.
Submitted by Argentum Medical, LLC (Geneva, US). The FDA issued a Cleared decision on January 14, 2019, 315 days after receiving the submission on March 5, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K180570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2018 |
| Decision Date | January 14, 2019 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |