K202982 is an FDA 510(k) clearance for the Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use). This device is classified as a Dressing, Wound, Drug.
Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 19, 2021, 384 days after receiving the submission on September 30, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K202982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2020 |
| Decision Date | October 19, 2021 |
| Days to Decision | 384 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |