FDA 510(k), K170574, Diacap Pro Dialyzer
FDA 510(k), K170574, Diacap Pro Dialyzer
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510(K) Number: K170574
Device Name: Diacap Pro Dialyzer
Manufacturer: Giuliana Gavioli
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 02/27/2017
Date Received: 08/11/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Diacap Pro Dialyzer
Manufacturer: Giuliana Gavioli
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 02/27/2017
Date Received: 08/11/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
- 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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