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

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