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FDA 510(k), K151525, Amia Automated PD System with Sharesource
FDA 510(k), K151525, Amia Automated PD System with Sharesource
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510(K) Number: K151525
Device Name: Amia Automated PD System with Sharesource
Manufacturer: DEKA RESEARCH AND DEVELOPMENT
Device Classification Name: system, peritoneal, automatic delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 06/08/2015
Decision Date: 10/09/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Amia Automated PD System with Sharesource
Manufacturer: DEKA RESEARCH AND DEVELOPMENT
Device Classification Name: system, peritoneal, automatic delivery
Regulation Number: 876.5630
Classification Product Code: FKX
Date Received: 06/08/2015
Decision Date: 10/09/2015
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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