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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 K140199
Device Name VUPAD
Applicant
Sonomed, Inc.
1979 Marcus Ave., Suite 105c
Lake Success,  NY  11042
Applicant Contact CHARLES C O'NEAL
Correspondent
Sonomed, Inc.
1979 Marcus Ave., Suite 105c
Lake Success,  NY  11042
Correspondent Contact CHARLES C O'NEAL
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received01/27/2014
Decision Date 04/01/2014
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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