FDA 510(k) Application Details - K132882

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K132882
Device Name	Pump, Breast, Powered
Applicant	SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD 7TH FLOOR, JINGUI BUSINESS BLDG, NO.982 CONGYUN RD BAIYUN DISTRICT GUANGZHOU, GUANGDONG 510420 CN Other 510(k) Applications for this Company
Contact	MIKE GU 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	09/13/2013
Decision Date	04/24/2014
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