The following data is part of a premarket notification filed by Chongqing Coe Display Technology Co., Ltd. with the FDA for Disposable Medical Surgical Mask.
| Device ID | K202759 |
| 510k Number | K202759 |
| Device Name: | Disposable Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Chongqing COE Display Technology Co., Ltd. No. 3, Tonggui Avenue, Yufengshan Town, Yubei District Chongqing, CN 401120 |
| Contact | Liu Qingjun |
| Correspondent | James Tsai Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-04-21 |