FDA 510(k) Application Details - K200815

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K200815
Device Name	Labware, Assisted Reproduction
Applicant	ORIGIO a/s Knardrupvej 2 Malov 2760 DK Other 510(k) Applications for this Company
Contact	Christine Kupchick 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	03/30/2020
Decision Date	06/25/2020
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