FDA 510(k) Application Details - K081463

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K081463
Device Name	Pump, Breast, Powered
Applicant	MEDEL S.P.A. 112 CAVISTION WAY CARY, NC 27519 US Other 510(k) Applications for this Company
Contact	TERRENCE O'BRIEN 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	05/23/2008
Decision Date	02/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review