3M Bair Hugger Universal Warming Gown Made With Thinsulate Insulation

System, Thermal Regulating

3M Company

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Bair Hugger Universal Warming Gown Made With Thinsulate Insulation.

Pre-market Notification Details

Device IDK210605
510k NumberK210605
Device Name:3M Bair Hugger Universal Warming Gown Made With Thinsulate Insulation
ClassificationSystem, Thermal Regulating
Applicant 3M Company 2510 Conway Ave. St. Paul,  MN  55144
ContactHilary Hovde
CorrespondentHilary Hovde
3M Company 2510 Conway Ave. St. Paul,  MN  55144
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-04-29

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