COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE


Device Classification Name

electrode, cutaneous

510(k) Number K080386
Device Name COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
Applicant
COLUMBIA SCIENTIFIC DEVELOPMENT LLC
420 nw 11th avenue
suite 617
portland, 
OR 
97209

Applicant Contact stephen shulman
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 02/13/2008
Decision Date 05/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No