FDA 510(k) Application Details - K082802

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K082802
Device Name	Pump, Breast, Powered
Applicant	LEARNING CURVE BRANDS INC. THE FIRST YEARS 100 TECHNOLOGY CTR. DR. SUITE 2A STOUGHTON, MA 02072 US Other 510(k) Applications for this Company
Contact	SUPRAVAN KHONGKRUAPHAN 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	09/24/2008
Decision Date	10/09/2008
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