The following data is part of a premarket notification filed by Wuhan Raytex Protection Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K203161 |
| 510k Number | K203161 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Wuhan Raytex Protection CO., LTD RM1201,Mingchuang Building,Greenland,Heping Avenue, Wuchang District Wuhan, CN 430060 |
| Contact | Maggie Yao |
| Correspondent | Maggie Yao Wuhan Raytex Protection CO., LTD RM1201,Mingchuang Building,Greenland,Heping Avenue, Wuchang District Wuhan, CN 430060 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-23 |
| Decision Date | 2022-01-20 |