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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K032026
Device Name LCD MONITOR, RADIFORCE G11, G31, G51
Applicant
Eizo Nanao Corporation
153 Shimokashiwano-Cho
Matto-Shi
Ishikawa-Ken,  JP 924-8566
Applicant Contact KAY HAMAGUCHI
Correspondent
Eizo Nanao Corporation
153 Shimokashiwano-Cho
Matto-Shi
Ishikawa-Ken,  JP 924-8566
Correspondent Contact KAY HAMAGUCHI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/30/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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