FDA 510(k), K091978, DBB-06 HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k), K091978, DBB-06 HEMODIALYSIS DELIVERY SYSTEM

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510(K) Number: K091978
Device Name: DBB-06 HEMODIALYSIS DELIVERY SYSTEM
Manufacturer: FUMIAKI KANAI
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 07/01/2009
Decision Date: 03/25/2010
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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