FDA 510(k) Application Details - DEN120015

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN120015
Device Name	EEVA 2.0
Applicant	AUXOGYN, INC. 1171 BARROILHET DRIVE HILLSBOROUGH, CA 94010 US Other 510(k) Applications for this Company
Contact	CINDY DOMECUS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2012
Decision Date	06/06/2014
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review