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510(k) K153162

Hypocore by Novocor Medical Systems, Inc. — Product Code NCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2016
Date Received
November 2, 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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  • K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (October 17, 2008)
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