The following data is part of a premarket notification filed by Naton Biotechnology (beijing) Co., Ltd. with the FDA for Naton Disposable Surgical Face Mask.
| Device ID | K201853 |
| 510k Number | K201853 |
| Device Name: | Naton Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Naton Biotechnology (Beijing) Co., Ltd. No. 9, Chengwan Street, Haidian District Beijing, CN 100094 |
| Contact | Shanshan Zou |
| Correspondent | Shanshan Zou Naton Biotechnology (Beijing) Co., Ltd. No. 9, Chengwan Street, Haidian District Beijing, CN 100094 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2021-04-23 |