FDA 510(k) Application Details - K191802

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K191802
Device Name	Pump, Breast, Powered
Applicant	Ningbo Huiyoo Baby Products Co. Ltd. 523# Cizhang Road, Zhangqi Industrial Area Cixi 315313 CN Other 510(k) Applications for this Company
Contact	Xiaoping Liu 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	07/03/2019
Decision Date	01/16/2020
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