Device Classification Name |
mask, surgical
|
510(k) Number |
K210225 |
Device Name |
Surgical Face Mask |
Applicant |
Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd |
Room 1304, Technology Innovation Park, |
Shajing Dahong (Xinqiao), Baoan District |
Shenzhen,
CN
518000
|
|
Applicant Contact |
Qiyuan Ning |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 01/28/2021 |
Decision Date | 03/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|