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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K062168
Device Name CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
Applicant
NEMOTO KYORINDO CO., LTD.
2-27-20 HONGO BUNKYO-KU
TOKYO,  JP 123-0033
Applicant Contact TOSHIO KANETAKA
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.1650
Classification Product Code
DXT  
Date Received07/31/2006
Decision Date 08/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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