FDA 510(k) Application Details - K190575

Device Classification Name	System, Documentation, Breast Lesion   More FDA Info for this Device
510(K) Number	K190575
Device Name	System, Documentation, Breast Lesion
Applicant	UE LifeSciences Inc. 3401 Market St, Suite 200 Philadelphia, PA 19104 US Other 510(k) Applications for this Company
Contact	Mihir Shah Other 510(k) Applications for this Contact
Regulation Number	884.2990   More FDA Info for this Regulation Number
Classification Product Code	NKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2019
Decision Date	07/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review