510(k) K072964

NICOLET CORTICAL STIMULATOR by Cardinal Health, Inc. — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2008
Date Received
October 19, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type