The following data is part of a premarket notification filed by Guangdong Haiou Medical Apparatus Co., Ltd. with the FDA for Disposable Medical Surgical Face Mask.
| Device ID | K203200 |
| 510k Number | K203200 |
| Device Name: | Disposable Medical Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong Haiou Medical Apparatus Co., Ltd. Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China Puning, CN 515300 |
| Contact | Zhang Zhuo Xuan |
| Correspondent | Salon Chen IMD Medical & Drug Technology Service Institutions Tianbao Office Room 225,Sha Tai Road No.209 Shenzhen City, CN 518117 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-29 |
| Decision Date | 2021-06-16 |