K180634 is an FDA 510(k) clearance for the Surgical Silver Post Operative Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Advanced Medical Solutions, Ltd. (Winsford, GB). The FDA issued a Cleared decision on August 7, 2018, 148 days after receiving the submission on March 12, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K180634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2018 |
| Decision Date | August 07, 2018 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |