510(k) K063304

LIFE4C by Numedis, Inc. — Product Code LYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2007
Date Received
November 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Corneal Storage
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type