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FDA 510(k), K050525, NXSTAGE SYSTEM ONE
FDA 510(k), K050525, NXSTAGE SYSTEM ONE
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510(K) Number: K050525
Device Name: NXSTAGE SYSTEM ONE
Manufacturer: NORMA LEMAY
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 03/02/2005
Date Received: 06/24/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NXSTAGE SYSTEM ONE
Manufacturer: NORMA LEMAY
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 03/02/2005
Date Received: 06/24/2005
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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