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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Ave.
Suite 617
Portland,  OR  97209
Applicant Contact STEPHEN SHULMAN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/13/2008
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
Predetermined Change
Control Plan Authorized		 No
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