FDA 510(k) Application Details - K190810

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K190810
Device Name	Pump, Breast, Powered
Applicant	Unimom Co. 110-19, Gajangsaneopseobuk-ro Osan-si 18102 KR Other 510(k) Applications for this Company
Contact	Sang-Hyun Hong Other 510(k) Applications for this Contact
Regulation Number	884.5160   More FDA Info for this Regulation Number
Classification Product Code	HGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2019
Decision Date	08/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review