The following data is part of a premarket notification filed by Shanghai Hua En Industrial Co Ltd with the FDA for Surgical Face Mask (hnfm0103).
| Device ID | K221838 |
| 510k Number | K221838 |
| Device Name: | Surgical Face Mask (HNFM0103) |
| Classification | Mask, Surgical |
| Applicant | Shanghai Hua En Industrial CO LTD #30, NO988 Hui Ji Road, Xuanqiao Town, Pudong Shanghai, CN 201314 |
| Contact | Lisa Zhao |
| 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 | 2022-06-23 |
| Decision Date | 2022-08-17 |