FDA 510(k) Application Details - K162409

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K162409
Device Name	Media, Reproductive
Applicant	GENEA BIOMEDX PTY LTD LEVEL 2, 321 KENT STREET SYDNEY 2000 AU Other 510(k) Applications for this Company
Contact	Kea Dent Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2016
Decision Date	05/24/2017
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