The following data is part of a premarket notification filed by Xiamen Eagledon Pharmaceutical Co., Ltd with the FDA for Disposable Surgical Mask.
| Device ID | K210267 |
| 510k Number | K210267 |
| Device Name: | Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Xiamen Eagledon Pharmaceutical Co., Ltd No.220-228, Meihe 3rd Road Xiamen, CN 361100 |
| Contact | Aggie Zhang |
| Correspondent | Ruth Wu Kavalan Consulting Inc. 1100 First Ave. Ste 305 King Of Prussia, PA 19406 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-07-08 |