Device Classification Name |
system, thermal regulating
|
510(k) Number |
K210605 |
Device Name |
3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation |
Applicant |
3M Company |
2510 Conway Ave. |
St. Paul,
MN
55144
|
|
Applicant Contact |
Hilary Hovde |
Correspondent |
3M Company |
2510 Conway Ave. |
St. Paul,
MN
55144
|
|
Correspondent Contact |
Hilary Hovde |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 03/01/2021 |
Decision Date | 04/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|