FDA 510(k) Application Details - K160274

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K160274
Device Name	Pump, Breast, Powered
Applicant	BISTOS CO., LTD. 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam 13201 KR Other 510(k) Applications for this Company
Contact	Jenny Cho 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	02/02/2016
Decision Date	09/01/2016
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