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 |