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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 K012099
Device Name MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
Applicant
Totoku Electric Co., Ltd.
319 Akeno
Obata-Cho, Watarai-Gun
Mie-Ken,  JP 519-05
Applicant Contact MIKIO HASEGAWA
Correspondent
Totoku Electric Co., Ltd.
319 Akeno
Obata-Cho, Watarai-Gun
Mie-Ken,  JP 519-05
Correspondent Contact MIKIO HASEGAWA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/05/2001
Decision Date 07/31/2001
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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