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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hypothermia, Intravenous, Cooling
510(k) Number K152946
Device Name TEMPEDY
Applicant
Seiratherm GmbH
Beethoven St.. 10
91074 Herzogenaurach,  DE 13033
Applicant Contact MATTHIAS ROTH
Correspondent
Philosopher'S River, LLC
P.O. Box 106
Willow Creek,  MT  59760
Correspondent Contact Mike Johnson
Regulation Number870.5900
Classification Product Code
NCX  
Date Received10/06/2015
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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