The following data is part of a premarket notification filed by Winner Medical Co., Ltd. with the FDA for Silver Alginate Dressing (prescription Use), Antibacterial Alginate Would Dressing (otc Use).
| Device ID | K202982 |
| 510k Number | K202982 |
| Device Name: | Silver Alginate Dressing (Prescription Use), Antibacterial Alginate Would Dressing (OTC Use) |
| Classification | Dressing, Wound, Drug |
| Applicant | Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 518109 |
| Contact | Haoyuan He |
| Correspondent | Haoyuan He Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 518109 |
| 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 | 2020-09-30 |
| Decision Date | 2021-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850044458466 | K202982 | 000 |
| 20850044458459 | K202982 | 000 |
| 20850044458442 | K202982 | 000 |