Device Classification Name |
Mask, Surgical
|
510(k) Number |
K191355 |
Device Name |
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask |
Applicant |
3M Health Care |
3M Center, 2510 Conway Ave., Building 275-5W-06 |
St. Paul,
MN
55144
|
|
Applicant Contact |
Angie Draper |
Correspondent |
3M Health Care |
3M Center, 2510 Conway Ave., Building 275-5W-06 |
St. Paul,
MN
55144
|
|
Correspondent Contact |
Angie Draper |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 05/21/2019 |
Decision Date | 09/11/2019 |
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
|
|
|