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FDA 510(k), K180194, SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
FDA 510(k), K180194, SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
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510(K) Number: K180194
Device Name: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Manufacturer: Paragonix Technologies, Inc.
Device Classification Name: system and accessories, isolated heart, transport and preservation
Regulation Number: 876.5880
Classification Product Code: MSB
Date Received: 01/24/2018
Decision Date: 03/30/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Manufacturer: Paragonix Technologies, Inc.
Device Classification Name: system and accessories, isolated heart, transport and preservation
Regulation Number: 876.5880
Classification Product Code: MSB
Date Received: 01/24/2018
Decision Date: 03/30/2018
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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