K192463 is an FDA 510(k) clearance for the PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border. This device is classified as a Dressing, Wound, Drug.
Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 14, 2020, 248 days after receiving the submission on September 9, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K192463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2019 |
| Decision Date | May 14, 2020 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |