The following data is part of a premarket notification filed by Winner Medical Co., Ltd. with the FDA for Silver Gelling Fiber Dressing.
| Device ID | K210466 |
| 510k Number | K210466 |
| Device Name: | Silver Gelling Fiber Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 51809 |
| Contact | Haoyuan He |
| Correspondent | Haoyuan He Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 51809 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-02-16 |
| Decision Date | 2022-01-14 |