The following data is part of a premarket notification filed by Jiangxi Feilikang Medical Technology Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K202904 |
| 510k Number | K202904 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangxi Feilikang Medical Technology Co., Ltd. Building 8, Anyuan Electronic Information Industry Park Pingxiang, CN 337000 |
| Contact | Shijun Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-01-21 |