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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, telethermographic (adjunctive use)
510(k) Number K113259
Device Name NOTOUCH BREASTSCAN
Original Applicant
UE LIFESCIENCES, INC.
4435 lobella court
chester springs,  PA  19425
Original Contact mihir shah
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received11/04/2011
Decision Date 02/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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