The following data is part of a premarket notification filed by Winner Medical Co., Ltd. with the FDA for Ag Foam Dressing Non-adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border.
| Device ID | K191819 |
| 510k Number | K191819 |
| Device Name: | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border |
| Classification | Dressing, Wound, Drug |
| Applicant | Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, CN 518109 |
| Contact | Dan Wang |
| Correspondent | Dan Wang 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 | 2019-07-05 |
| Decision Date | 2020-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850044458541 | K191819 | 000 |
| 20850044458534 | K191819 | 000 |
| 20850044458527 | K191819 | 000 |