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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 K171234
Device Name Mistral-Air Warming Unit
Applicant
The Surgical Company International BV (As the 37company)
Beeldschermweg 6f
Amersfoort,  NL 3821 AH
Applicant Contact Kees van Hassel
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/27/2017
Decision Date 05/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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