Device Classification Name |
mask, surgical
|
510(k) Number |
K202161 |
Device Name |
Surgical Face Mask |
Applicant |
Hunan EEXI Technology & Service Co., Ltd. |
No.6 North of Pingtou Road, Liuyang Hi-Tech Industrial |
Development Zone |
Liuyang,
CN
410300
|
|
Applicant Contact |
Zhang Xianliang |
Correspondent |
Shenzhen Joyantech Consulting Co.,Ltd. |
1713A, 17th Floor, Block A, Zhongguan Times Square, |
Nanshan District |
Shenzhen,
CN
518100
|
|
Correspondent Contact |
Joyce Joyce |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 08/03/2020 |
Decision Date | 03/10/2021 |
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
|
|
|