FDA 510(k) Application Details - K181461

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K181461
Device Name	Labware, Assisted Reproduction
Applicant	Vitrolife Sweden AB Gustaf Werners gata 2 Vastra Frolunda 421 32 SE Other 510(k) Applications for this Company
Contact	Nina Arvidsson Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2018
Decision Date	01/04/2019
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