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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K061519
Device Name MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
Applicant
NIKKISO CO. LTD.
4-2-1 YUSHIMA
BUNKYO-KU
TOKYO,  JP 113-0034
Applicant Contact FUMIAKI KANAI
Correspondent
NIKKISO CO. LTD.
4-2-1 YUSHIMA
BUNKYO-KU
TOKYO,  JP 113-0034
Correspondent Contact FUMIAKI KANAI
Regulation Number876.5860
Classification Product Code
KDI  
Date Received06/01/2006
Decision Date 09/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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