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FDA 510(k), K170469, NxStage System One Plus
FDA 510(k), K170469, NxStage System One Plus
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510(K) Number: K170469
Device Name: NxStage System One Plus
Manufacturer: Randall Covill
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 02/16/2017
Date Received: 05/09/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NxStage System One Plus
Manufacturer: Randall Covill
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 02/16/2017
Date Received: 05/09/2017
Decision Date: Substantially Equivalent (SESE)
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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