FDA 510(k) Application Details - K151061

Device Classification Name	Media, Corneal Storage   More FDA Info for this Device
510(K) Number	K151061
Device Name	Media, Corneal Storage
Applicant	EUROBIO 7, AVENUE DE SCANDINAVIE LES ULIS F-91953 FR Other 510(k) Applications for this Company
Contact	Marie-Claude Amoureux Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	08/06/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review