The following data is part of a premarket notification filed by Conod Medical Co., Limited with the FDA for Single-use Medical Face Mask.
| Device ID | K203591 |
| 510k Number | K203591 |
| Device Name: | Single-use Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Conod Medical Co., Limited No.11 Hongfeng Road, Baimao Industrial Park, Guli Town, Changshu, CN 215532 |
| Contact | Carrie Wu |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-08 |
| Decision Date | 2021-07-02 |