FDA 510(k) Application Details - K242111

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K242111
Device Name	Pump, Breast, Powered
Applicant	Unimom.Co 110-19, Gajangsaneopseobuk-ro Osan-si 18102 KR Other 510(k) Applications for this Company
Contact	Yeong-Bin Chon 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	07/19/2024
Decision Date	02/06/2025
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