FDA 510(k) Application Details - K954548

Device Classification Name	Media, Corneal Storage   More FDA Info for this Device
510(K) Number	K954548
Device Name	Media, Corneal Storage
Applicant	CHEN OPHTHALMIC LABORATORIES 13704 KILLARNEY COURT PHOENIX, MD 21131 US Other 510(k) Applications for this Company
Contact	CHUNG-HO CHEN 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	10/02/1995
Decision Date	05/20/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review