Device Classification Name |
mask, surgical
|
510(k) Number |
K152197 |
Device Name |
Skypro, SP01 Mask |
Applicant |
Skypro Medical Supplies Company |
C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat |
1-33 Cheung Tat Road, Tsing Yi, NT |
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, NT |
hong kong,
CN
|
|
Correspondent Contact |
cyrus wong |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 08/05/2015 |
Decision Date | 08/26/2016 |
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
|
|
|