SUBDURAL STRIP ELECTRODE


Device Classification Name

electrode, cortical

510(k) Number K021144
Device Name SUBDURAL STRIP ELECTRODE
Original Applicant
NICOLET BIOMEDICAL, INC.
800 levanger ln.
stoughton, 
WI 
53589

Original Contact gary syring
Regulation Number 882.1310
Classification Product Code
GYC  
Date Received 04/09/2002
Decision Date 06/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No