FDA 510(k) Application Details - K202989

Device Classification Name	Device,Analysis,Anterior Segment   More FDA Info for this Device
510(K) Number	K202989
Device Name	Device,Analysis,Anterior Segment
Applicant	OCULUS OptikgerΣte GmbH MⁿnchholzhΣuser Stra▀e 29 Wetzlar 35582 DE Other 510(k) Applications for this Company
Contact	Eckhard Loh Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	MXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2020
Decision Date	07/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review