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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 Doppler, Ultrasonic
510(k) Number K982498
Device Name DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Volumetrics Medical Imaging, Inc.
700 Main St.
Durham,  NC  27701
Applicant Contact JIM MUNDELL
Correspondent
Volumetrics Medical Imaging, Inc.
700 Main St.
Durham,  NC  27701
Correspondent Contact JIM MUNDELL
Regulation Number892.1550
Classification Product Code
IYN  
Date Received07/17/1998
Decision Date 08/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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