The following data is part of a premarket notification filed by Lucky Textile Industrial(wuxi) Co.,ltd. with the FDA for Disposable Surgical Mask.
| Device ID | K203756 |
| 510k Number | K203756 |
| Device Name: | Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Lucky Textile Industrial(Wuxi) Co.,Ltd. No.10 Zhuqiao Road, Yixing Economic and Technological Development Zone ,Yixing, Jiangsu, China Yixing, CN 214200 |
| Contact | Grace Tai |
| Correspondent | Grace Tai Lucky Textile Industrial(Wuxi) Co.,Ltd. No.10 Zhuqiao Road, Yixing Economic And Technological Development Zone ,Yixing, Jiangsu, China Yixing, CN 214200 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2021-06-10 |