NICOLET CORTICAL STIMULATOR


Device Classification Name

electrode, cortical

510(k) Number K072964
Device Name NICOLET CORTICAL STIMULATOR
Applicant
CARDINAL HEALTH, INC.
800 levanger lane
stoughton, 
WI 
53589

Applicant Contact gary syring
Correspondent
CARDINAL HEALTH, INC.
800 levanger lane
stoughton, 
WI 
53589

Correspodent Contact gary syring
Regulation Number 882.1310
Classification Product Code
GYC  
Subsequent Product Code
ETN  
Date Received 10/19/2007
Decision Date 12/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls