The following data is part of a premarket notification filed by Han Zhaoqing Sporting Goods Company Limited with the FDA for Procedure Face Mask (model: Kkf-2a).
| Device ID | K202314 |
| 510k Number | K202314 |
| Device Name: | Procedure Face Mask (Model: KKF-2A) |
| Classification | Mask, Surgical |
| Applicant | Han Zhaoqing Sporting Goods Company Limited NO.2-1, Kang Tai Street, High-tech Zone, Zhaoqing City, Guangdong ,China Zhaoqing, CN 526238 |
| Contact | Zhang Ming |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN 510700 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2021-01-13 |