FDA 510(k) Application Details - K081932

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K081932
Device Name	Pump, Breast, Powered
Applicant	HYGEIA MEDICAL, INC. 6353 CORTE DEL ABETO SUITE 102 CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	JASPER BENKE 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	07/07/2008
Decision Date	01/22/2009
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