Device Classification Name |
mask, surgical
|
510(k) Number |
K202463 |
Device Name |
Disposable Surgical Mask |
Applicant |
Unisources Group LLC |
7460 NW 52nd Street |
Miami,
FL
33166
|
|
Applicant Contact |
Henry Shen |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 08/27/2020 |
Decision Date | 09/18/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|