The following data is part of a premarket notification filed by Hubei Medlink Healthcare Co., Ltd with the FDA for Medical Face Mask.
| Device ID | K214087 |
| 510k Number | K214087 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Hubei Medlink Healthcare Co., Ltd 36F, Tower1, New World International Trade Tower 568 Jianshe Avenue Wuhan, CN 430000 |
| Contact | Sophie Liu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central 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 | 2021-12-27 |
| Decision Date | 2022-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853927007730 | K214087 | 000 |
| 20850044799798 | K214087 | 000 |