K070581 is an FDA 510(k) clearance for the SILVER ALGINATE II 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 July 13, 2007, 134 days after receiving the submission on March 1, 2007.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K070581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2007 |
| Decision Date | July 13, 2007 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |