Device Classification Name |
Mask, Surgical
|
510(k) Number |
K201479 |
Device Name |
DemeMASK |
Applicant |
DemeTECH Corporation |
14175 NW 60th Avenue |
Miami Lakes,
FL
33014
|
|
Applicant Contact |
Tracy Chadwrick |
Correspondent |
DemeTECH Corporation |
14175 NW 60th Avenue |
Miami Lakes,
FL
33014
|
|
Correspondent Contact |
Tracy Chadwrick |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 06/04/2020 |
Decision Date | 07/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|