FDA 510(k) Application Details - K101538

Device Classification Name	Pump, Breast, Non-Powered   More FDA Info for this Device
510(K) Number	K101538
Device Name	Pump, Breast, Non-Powered
Applicant	PHILIPS ELECTRONICS UK LIMITED PAMPISFORD ROAD GREAT ABINGTON, CAMBRIDGE CB21 6AH GB Other 510(k) Applications for this Company
Contact	DIANA KORDA HEWITT Other 510(k) Applications for this Contact
Regulation Number	884.5150   More FDA Info for this Regulation Number
Classification Product Code	HGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2010
Decision Date	11/05/2010
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	N
Expedited Review