K090453 is an FDA 510(k) clearance for the SILVER ALGINATE 11 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 February 26, 2009, 3 days after receiving the submission on February 23, 2009.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K090453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2009 |
| Decision Date | February 26, 2009 |
| Days to Decision | 3 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |