The following data is part of a premarket notification filed by Hunan Eexi Technology & Service Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K202161 |
| 510k Number | K202161 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Hunan EEXI Technology & Service Co., Ltd. No.6 North Of Pingtou Road, Liuyang Hi-Tech Industrial Development Zone Liuyang, CN 410300 |
| Contact | Zhang Xianliang |
| Correspondent | Joyce Joyce Shenzhen Joyantech Consulting Co.,Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518100 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2021-03-10 |