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FDA 510(k), K171671, Prismaflex System 8.10
FDA 510(k), K171671, Prismaflex System 8.10
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510(K) Number: K171671
Device Name: Prismaflex System 8.10
Manufacturer: Baxter Healthcare Corporation
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 06/06/2017
Decision Date: 02/23/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Prismaflex System 8.10
Manufacturer: Baxter Healthcare Corporation
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 06/06/2017
Decision Date: 02/23/2018
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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