The following data is part of a premarket notification filed by Hubei Huaqiang High-tech Co., Ltd. with the FDA for Disposable Medical Surgical Mask.
| Device ID | K212726 |
| 510k Number | K212726 |
| Device Name: | Disposable Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Hubei Huaqiang High-Tech Co., Ltd. No.499 DongLin Road Yichang, CN 443000 |
| Contact | Jing Yang |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. Fangshan District, CN 102401 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2022-03-23 |