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510(k) K152946

TEMPEDY by Seiratherm GmbH — Product Code NCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2016
Date Received
October 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hypothermia, Intravenous, Cooling
Device Class
Class II
Regulation Number
870.5900
Review Panel
NE
Submission Type

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