FDA 510(k), K162248, Asahi ViE-U Series Dialyzer

FDA 510(k), K162248, Asahi ViE-U Series Dialyzer

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510(K) Number: K162248
Device Name: Asahi ViE-U Series Dialyzer
Manufacturer: Masaharu Aritomi
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 08/10/2016
Decision Date: 05/03/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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