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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K897042
Device Name EUB-515 DIAGNOSTIC ULTRASOUND DEVICE
Applicant
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Applicant Contact TAKIGUCHI
Correspondent
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Correspondent Contact TAKIGUCHI
Regulation Number892.1560
Classification Product Code
IYO  
Date Received12/18/1989
Decision Date 09/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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