FDA 510(k) Application Details - K183486

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K183486
Device Name	Media, Reproductive
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	884.6180   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	12/17/2018
Decision Date	07/26/2019
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