FDA 510(k) Application Details - K142168

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K142168
Device Name	Pump, Breast, Powered
Applicant	DEVON MEDICAL PRODUCTS, INC. 1100 FIRST AVENUE, SUITE 202 KING OF PRUSSIA, PA 19406 US Other 510(k) Applications for this Company
Contact	Ruth Wu 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	08/06/2014
Decision Date	12/04/2014
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	Y
Expedited Review