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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 K984161
Device Name CTS-310(B)
Applicant
Shantou Institute of Ultrasonic Instuments
1106 Chiltern Dr.
Walnut Creek,  CA  94596
Applicant Contact ROBERT MORTON
Correspondent
Shantou Institute of Ultrasonic Instuments
1106 Chiltern Dr.
Walnut Creek,  CA  94596
Correspondent Contact ROBERT MORTON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/20/1998
Decision Date 05/05/1999
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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