Device Classification Name |
Mask, Surgical
|
510(k) Number |
K955382 |
Device Name |
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 |
Applicant |
3M COMPANY |
BUILDINGS 251-3 AND 270 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
DOROTHEA VON BUSCH |
Correspondent |
3M COMPANY |
BUILDINGS 251-3 AND 270 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
DOROTHEA VON BUSCH |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 11/24/1995 |
Decision Date | 05/01/1996 |
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
|
|
|