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FDA 510(k), K161602, Arctic Sun Temperature Management System
FDA 510(k), K161602, Arctic Sun Temperature Management System
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510(K) Number: K161602
Device Name: Arctic Sun Temperature Management System
Manufacturer: Medivance, Inc.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 06/09/2016
Decision Date: 09/02/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Arctic Sun Temperature Management System
Manufacturer: Medivance, Inc.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 06/09/2016
Decision Date: 09/02/2016
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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