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FDA 510(k), K171331, NxStage System One
FDA 510(k), K171331, NxStage System One
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$149.00 USD
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510(K) Number: K171331
Device Name: NxStage System One
Manufacturer: NxStage Medical, Inc.
Device Classification Name: dialyzer, high permeability with or without sealed dialysate system
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 05/08/2017
Decision Date: 08/24/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NxStage System One
Manufacturer: NxStage Medical, Inc.
Device Classification Name: dialyzer, high permeability with or without sealed dialysate system
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 05/08/2017
Decision Date: 08/24/2017
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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