Device Classification Name |
mask, surgical
|
510(k) Number |
K152561 |
Device Name |
Communicator Surgical Facemask with Clear Window |
Applicant |
Prestige Ameritech, Ltd |
7201 Iron Horse Blvd. |
North Richland Hills,
TX
76180
|
|
Applicant Contact |
Rex Reese |
Correspondent |
Prestige Ameritech, Ltd. |
7201 Iron Horse Blvd. |
North Richland Hills,
TX
76180
|
|
Correspondent Contact |
Rex Reese |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/09/2015 |
Decision Date | 06/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|