FDA 510(k) Application Details - K052909

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K052909
Device Name	Pump, Breast, Powered
Applicant	EVENFLO COMPANY, INC. 707 CROSSROADS COURT VANDALIA, OH 45377 US Other 510(k) Applications for this Company
Contact	THOMAS A SPARNO 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	10/17/2005
Decision Date	11/01/2005
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	Y
Expedited Review