Device Classification Name |
Surgical Mask With Antimicrobial/Antiviral Agent
|
510(k) Number |
K231741 |
Device Name |
ProGear® Surgical Mask with Oxafence®, Model AV82030 |
Applicant |
Prestige Ameritech |
7201 Iron Horse Blvd. |
North Richland Hills,
TX
76180
|
|
Applicant Contact |
Hofheinz Danica |
Correspondent |
Prestige Ameritech |
7201 Iron Horse Blvd. |
North Richland Hills,
TX
76180
|
|
Correspondent Contact |
Danica Hofheinz |
Regulation Number | 878.4040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/2023 |
Decision Date | 09/05/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|