K230190 is an FDA 510(k) clearance for the Polyver Silver Alginate Dressing (Prescription and OTC). This device is classified as a Dressing, Wound, Drug.
Submitted by Roosin Medical Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on November 17, 2023, 297 days after receiving the submission on January 24, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K230190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2023 |
| Decision Date | November 17, 2023 |
| Days to Decision | 297 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |