Device Classification Name |
mask, surgical
|
510(k) Number |
K223068 |
Device Name |
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) |
Applicant |
Guangdong Golden Leaves Technology Development Co., LTD |
5/F, Building 2, No. 8, Qiaolonghe East Road |
Tangxia Town |
Dongguan,
CN
523730
|
|
Applicant Contact |
Wenhong Zhou |
Correspondent |
Share Info (Guangzhou) Medical Consultant Ltd. |
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road |
Huangpu District |
Guangzhou,
CN
523000
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/30/2022 |
Decision Date | 11/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|