Device Classification Name |
mask, surgical
|
510(k) Number |
K202594 |
Device Name |
Medical Surgical Masks-Non Sterile |
Applicant |
Shandong T&F Nonwoven Co., LTD |
South of Shuangyong Road, Chengyang District |
Qingdao,
CN
266100
|
|
Applicant Contact |
Minsheng Zhao |
Correspondent |
Beijing Believe-Med Technology Service Co., Ltd. |
Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., |
FangShan District |
Beijing,
CN
102401
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/08/2020 |
Decision Date | 01/06/2021 |
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
|
|
|