The following data is part of a premarket notification filed by Chaozhou Cecilia Technology Co., Ltd. with the FDA for Disposable Face Mask.
| Device ID | K203152 |
| 510k Number | K203152 |
| Device Name: | Disposable Face Mask |
| Classification | Mask, Surgical |
| Applicant | Chaozhou Cecilia Technology Co., Ltd. Nanyuan Building A, Xiakeng, Yintan, Wenci, Chaozhou, Guangdong, China Chaozhou, CN 515658 |
| Contact | Weng Yu |
| 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 | 2020-10-22 |
| Decision Date | 2021-08-11 |