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FDA 510(k), K121720, WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
FDA 510(k), K121720, WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
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510(K) Number: K121720
Device Name: WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
Manufacturer: WELKINS, LLC
Device Classification Name: system, thermal regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 06/12/2012
Decision Date: 08/20/2012
Regulation Medical Specialty: Cardiovascular
Device Name: WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
Manufacturer: WELKINS, LLC
Device Classification Name: system, thermal regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 06/12/2012
Decision Date: 08/20/2012
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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