FDA 510(k) Application Details - K030719

Device Classification Name	Device,Analysis,Anterior Segment   More FDA Info for this Device
510(K) Number	K030719
Device Name	Device,Analysis,Anterior Segment
Applicant	OCULUS OPTIKGERATE GMBH 18902 NE 150TH ST. WOODINVILLE, WA 98072 US Other 510(k) Applications for this Company
Contact	TOM WEATHERBY 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	03/07/2003
Decision Date	09/16/2003
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