Device Classification Name |
Mask, Surgical
|
510(k) Number |
K211353 |
Device Name |
Medical Face Mask |
Applicant |
Shenzhen Lyttop Healthcare Limited |
A201, building 7, Dongjiu innovation and Technology Park II, |
73 Xiali South Road, Longgang District |
Shenzhen,
CN
518114
|
|
Applicant Contact |
Lily Wu |
Correspondent |
Shanghai Sungo Management Consulting Company Limited |
14th Floor, 1500# Central Avenue |
Shangghai,
CN
200122
|
|
Correspondent Contact |
Ivy Wang |
Regulation Number | 878.4040 |
Classification Product Code |
|
Date Received | 05/03/2021 |
Decision Date | 08/11/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|