FDA 510(k) Application Details - K212564

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K212564
Device Name	Pump, Breast, Powered
Applicant	Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street Chaoyang District Shantou 515100 CN Other 510(k) Applications for this Company
Contact	Changxin Chen 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	08/13/2021
Decision Date	05/06/2022
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