FDA 510(k) Application Details - K100929

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K100929
Device Name	Pump, Breast, Powered
Applicant	BLUE EGG CO 216-5 YONGMOON-DONG, SEO-KU DAEJON, KOREA KR Other 510(k) Applications for this Company
Contact	HONG J HYUN 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	04/05/2010
Decision Date	06/16/2010
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