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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K082719
Device Name NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
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 Number876.5820
Classification Product Code
KOC  
Date Received09/17/2008
Decision Date 03/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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