Device Classification Name |
respirator, surgical
|
510(k) Number |
K020474 |
Device Name |
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 |
Applicant |
MAKRITE INDUSTRIES, INC. |
24 TOWER ST. |
webster,
MA
01570
|
|
Applicant Contact |
joseph z zdrok |
Correspondent |
MAKRITE INDUSTRIES, INC. |
24 TOWER ST. |
webster,
MA
01570
|
|
Correspondent Contact |
joseph z zdrok |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 02/12/2002 |
Decision Date | 07/23/2002 |
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
|
|
|