FDA 510(k) Application Details - K161970

Device Classification Name	Needle, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K161970
Device Name	Needle, Assisted Reproduction
Applicant	VITROLIFE SWEDEN AB GUSTAF WERNERS GATA 2 VASTRA FROLUNDA SE-421 32 SE Other 510(k) Applications for this Company
Contact	ANJA BENGTZELIUS Other 510(k) Applications for this Contact
Regulation Number	884.6100   More FDA Info for this Regulation Number
Classification Product Code	MQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2016
Decision Date	06/14/2017
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