FDA 510(k) Application Details - K180304

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K180304
Device Name	Accessory, Assisted Reproduction
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	884.6120   More FDA Info for this Regulation Number
Classification Product Code	MQG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2018
Decision Date	04/20/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review