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FDA 510(k), K072234, THERMOGARD XP THERMAL REGULATION SYSTEM
FDA 510(k), K072234, THERMOGARD XP THERMAL REGULATION SYSTEM
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510(K) Number: K072234
Device Name: THERMOGARD XP THERMAL REGULATION SYSTEM
Manufacturer: ALSIUS CORP.
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 08/10/2007
Decision Date: 08/23/2007
Regulation Medical Specialty: Cardiovascular
Device Name: THERMOGARD XP THERMAL REGULATION SYSTEM
Manufacturer: ALSIUS CORP.
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 08/10/2007
Decision Date: 08/23/2007
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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