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FDA 510(k), K143054, Sherpa Pak Kidney Transport System
FDA 510(k), K143054, Sherpa Pak Kidney Transport System
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510(K) Number: K143054
Device Name: Sherpa Pak Kidney Transport System
Manufacturer: PARAGONIX TECHNOLOGIES, INC.
Device Classification Name: System, Perfusion, Kidney
Regulation Number: 876.5880
Classification Product Code: KDN
Date Received: 10/23/2014
Decision Date: 11/25/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Sherpa Pak Kidney Transport System
Manufacturer: PARAGONIX TECHNOLOGIES, INC.
Device Classification Name: System, Perfusion, Kidney
Regulation Number: 876.5880
Classification Product Code: KDN
Date Received: 10/23/2014
Decision Date: 11/25/2014
Regulation Medical Specialty: Gastroenterology/Urology
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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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