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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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.
Saint Paul,  MN  55144
Applicant Contact Hilary Hovde
Correspondent
3M Company
2510 Conway Ave.
Saint Paul,  MN  55144
Correspondent Contact Hilary Hovde
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/01/2021
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
Predetermined Change
Control Plan Authorized		 No
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