The following data is part of a premarket notification filed by Guangzhou Mei Yi Kang Medical Technology Co., Ltd. with the FDA for Disposable Medical Face Mask.
| Device ID | K203646 |
| 510k Number | K203646 |
| Device Name: | Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Guangzhou Mei Yi Kang Medical Technology CO., LTD. No. 43-31 Baofeng East Road, JinShi North Avenue, Shiling Town, Huada District Guangzhou, CN 510800 |
| Contact | Lou Yonghui |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN 510000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2021-04-22 |