FDA 510(k) Application Details - K102516

Device Classification Name	Pump, Breast, Powered   More FDA Info for this Device
510(K) Number	K102516
Device Name	Pump, Breast, Powered
Applicant	GENADYNE BIOTECHNOLOGIES, INC. 65 WATERMILL LANE GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	CHIEN MING(ANDREW)GOH 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	09/02/2010
Decision Date	08/11/2011
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