Device Classification Name |
respirator, surgical
|
510(k) Number |
K063023 |
Device Name |
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 |
Applicant |
3M COMPANY |
3M CENTER BUILDING 275-05W-06 |
ST. PAUL,
MN
55144
|
|
Applicant Contact |
DIANNE GIBBS |
Correspondent |
3M COMPANY |
3M CENTER BUILDING 275-05W-06 |
ST. PAUL,
MN
55144
|
|
Correspondent Contact |
DIANNE GIBBS |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 10/02/2006 |
Decision Date | 02/23/2007 |
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
|
|
|