The following data is part of a premarket notification filed by Hunan Chopard Medical Devices Co., Ltd with the FDA for Medical Surgical Mask (planar Type).
| Device ID | K220824 |
| 510k Number | K220824 |
| Device Name: | Medical Surgical Mask (Planar Type) |
| Classification | Mask, Surgical |
| Applicant | Hunan Chopard Medical Devices Co., Ltd 88, Tongxin Road, Longfu Town Industrial District, Liuyang City, Hunan Province Liuyang, CN |
| Contact | Hongwei Wei |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-05-19 |