FDA 510(k) Application Details - K202802

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K202802
Device Name	Pump, Breast, Powered
Applicant	Wuxi Xinzhongrui Baby Supplies Co., Ltd. No. 117 Xinhua Road, Meicun, New Wu District, Wuxi 214000 CN Other 510(k) Applications for this Company
Contact	Zhang Chunyan 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	09/23/2020
Decision Date	08/26/2021
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