The following data is part of a premarket notification filed by Shenzhen Lyttop Healthcare Limited with the FDA for Medical Face Mask.
| Device ID | K211353 |
| 510k Number | K211353 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Shenzhen Lyttop Healthcare Limited A201, Building 7, Dongjiu Innovation And Technology Park II, 73 Xiali South Road, Longgang District Shenzhen, CN 518114 |
| Contact | Lily Wu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shangghai, 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 | 2021-05-03 |
| Decision Date | 2021-08-11 |