FDA 510(k) Application Details - K043098

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K043098
Device Name	Pump, Breast, Powered
Applicant	GERBER PRODUCTS CO. 445 STATE ST. FREMONT, MI 49413 US Other 510(k) Applications for this Company
Contact	RANGA RANGANATHAN 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	11/09/2004
Decision Date	12/15/2004
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