FDA 510(k) Application Details - K172842

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K172842
Device Name	Pump, Breast, Powered
Applicant	Globalcare No7 factory European Ind. Park No. 39 mid Industrial main Rd Xiaolan Town, Zhongshan City 528415 CN Other 510(k) Applications for this Company
Contact	Chiara Cavagnolo 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	09/19/2017
Decision Date	06/18/2018
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