FDA 510(k) Application Details - K250365

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K250365
Device Name	Pump, Breast, Powered
Applicant	Shenzhen TPH Technology Co., Ltd. Room 203, 2nd floor, 29th Building, Lianchuang Technology Pa rk, No.21 Bulan Road, Xialilang Community, Nanwan Street, Lo Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Xiaoyan Yang 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	02/10/2025
Decision Date	05/30/2025
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