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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 K232508
Device Name Barrier EasyWarm Active Self-Warming Blanket
Applicant
Molnlycke Health Care Us, LLC
5445 Triangle Pkwy.
Suite 400
Peachtree Corners,  GA  30092
Applicant Contact Megan Bevill
Correspondent
Molnlycke Health Care Us, LLC
5445 Triangle Pkwy.
Suite 400
Peachtree Corners,  GA  30092
Correspondent Contact Megan Bevill
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/18/2023
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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