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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 K070982
Device Name CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
Applicant
Shantou Institute of Ultrasonic Instuments
7263 Cronin Circle
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Shantou Institute of Ultrasonic Instuments
7263 Cronin Circle
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received04/06/2007
Decision Date 05/02/2007
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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