FDA 510(k) Application Details - K172067

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K172067
Device Name	Pump, Breast, Powered
Applicant	Ardo medical AG Gewerbestrasse 19 Unterageri 6314 CH Other 510(k) Applications for this Company
Contact	Roger Dubach 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	07/07/2017
Decision Date	11/29/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review