FDA 510(k) Application Details - K192008

Device Classification Name	System, Assisted Reproduction Laser   More FDA Info for this Device
510(K) Number	K192008
Device Name	System, Assisted Reproduction Laser
Applicant	Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg 84079 DE Other 510(k) Applications for this Company
Contact	Susanne Schweitzer Other 510(k) Applications for this Contact
Regulation Number	884.6200   More FDA Info for this Regulation Number
Classification Product Code	MRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2019
Decision Date	03/25/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review