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FDA 510(k), K101092, ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
FDA 510(k), K101092, ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
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510(K) Number: K101092
Device Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 04/20/2010
Decision Date: 07/16/2010
Regulation Medical Specialty: Cardiovascular
Device Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 04/20/2010
Decision Date: 07/16/2010
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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