K080503 is an FDA 510(k) clearance for the SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on November 12, 2008, 261 days after receiving the submission on February 25, 2008.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K080503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2008 |
| Decision Date | November 12, 2008 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |