K110458 is an FDA 510(k) clearance for the SILVER ANTIMICROBIAL WOUND GEL. 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 March 14, 2011, 25 days after receiving the submission on February 17, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K110458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2011 |
| Decision Date | March 14, 2011 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |