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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, documentation, breast lesion
510(k) Number K190575
Device Name iBreastExam
Applicant
UE LifeSciences Inc.
3401 Market St, Suite 200
Philadelphia,  PA  19104
Applicant Contact Mihir Shah
Correspondent
UE LifeSciences Inc.
3401 Market St, Suite 200
Philadelphia,  PA  19104
Correspondent Contact Mihir Shah
Regulation Number884.2990
Classification Product Code
NKA  
Date Received03/06/2019
Decision Date 07/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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