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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 K962308
Device Name EUB-905
Applicant
Hitachi Medical Corp. of America
660 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact CHARLES F HOTTINGER, PH.D.
Correspondent
Hitachi Medical Corp. of America
660 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact CHARLES F HOTTINGER, PH.D.
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/17/1996
Decision Date 07/17/1996
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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