FDA 510(k), K152938, DBB-06 Hemodialysis Delivery System

FDA 510(k), K152938, DBB-06 Hemodialysis Delivery System

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510(K) Number: K152938
Device Name: DBB-06 Hemodialysis Delivery System
Manufacturer: SEIYA RAIJYU
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: 10/05/2015
Date Received: 03/18/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

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