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FDA 510(k), K071341, MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
FDA 510(k), K071341, MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
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510(K) Number: K071341
Device Name: MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 05/14/2007
Decision Date: 08/03/2007
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 05/14/2007
Decision Date: 08/03/2007
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks
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