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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 K063200
Device Name 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
Applicant
Totoku Electric Co., Ltd.
300 Oya
Ueda,  JP 386-0192
Applicant Contact MIKIO HASEGAWA
Correspondent
Totoku Electric Co., Ltd.
300 Oya
Ueda,  JP 386-0192
Correspondent Contact MIKIO HASEGAWA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/20/2006
Decision Date 12/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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