FDA 510(k) Application Details - K063304

Device Classification Name	Media, Corneal Storage   More FDA Info for this Device
510(K) Number	K063304
Device Name	Media, Corneal Storage
Applicant	NUMEDIS, INC. 188 BUMSTEAD RD. MONSON, MA 01057 US Other 510(k) Applications for this Company
Contact	MARY E FREDDO 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	11/01/2006
Decision Date	12/21/2007
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