FDA 510(k) Application Details - K173264

Device Classification Name	Accessory, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K173264
Device Name	Accessory, Assisted Reproduction
Applicant	Vitrolife A/S Jens Juuls Vej 20 Viby J 8260 DK Other 510(k) Applications for this Company
Contact	Belinda Dueholm 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	10/11/2017
Decision Date	05/11/2018
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