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510(k) K080908

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM by Innercool Therapies, Inc.- A Delaware Corporation — Product Code NCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2008
Date Received
April 1, 2008
Clearance Type
Special
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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