FDA 510(k) Application Details - K162013

Device Classification Name	Media, Corneal Storage   More FDA Info for this Device
510(K) Number	K162013
Device Name	Media, Corneal Storage
Applicant	AL.CHI.MI.A. S.r.l. Viale Austria 14 Ponte San Nicolo 35020 IT Other 510(k) Applications for this Company
Contact	Mauro Beccaro 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	07/21/2016
Decision Date	09/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review