Device Classification Name |
mask, surgical
|
510(k) Number |
K202255 |
Device Name |
Skypro, SP02 Mask (3) |
Applicant |
Skypro Medical Supplies Company |
C301, Tsing Yi Industrial Centre Phase 2, |
1-33 Cheung Tat Road, Tsing Yi, N.T. |
Hong Kong,
CN
|
|
Applicant Contact |
Cyrus Wong |
Correspondent |
Skypro Medical Supplies Company |
C301, Tsing Yi Industrial Centre Phase 2, |
1-33 Cheung Tat Road, Tsing Yi, N.T. |
Hong Kong,
CN
|
|
Correspondent Contact |
Cyrus Wong |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 08/10/2020 |
Decision Date | 12/24/2021 |
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
|
|
|