FDA 510(k) Application Details - K212884

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K212884
Device Name	Pump, Breast, Powered
Applicant	Dongguan Rongfeng Medical Co., Ltd. Room 201, No. 7 Xiangyuan Road, Shujiu Changping Town Dongguan 523570 CN Other 510(k) Applications for this Company
Contact	Qianqian Yu 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	09/10/2021
Decision Date	01/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review