510(k) K854052

CSM MEDIUM by Northern Scientific, Inc. — Product Code LYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1985
Date Received
October 3, 1985
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