Device Classification Name |
system, thermal regulating
|
510(k) Number |
K171373 |
Device Name |
3M Bair Hugger Model 675 Total Temperature Management System |
Applicant |
3M Company |
3M Center, Building 275-5W-06 |
St. Paul,
MN
55144
|
|
Applicant Contact |
Jon Platt |
Correspondent |
3M Company |
3M Center, Building 275-5W-06 |
St. Paul,
MN
55144
|
|
Correspondent Contact |
Jon Platt |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 05/10/2017 |
Decision Date | 10/10/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|