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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 K844097
Device Name CANMED 103 9300 ELECTRODE
Applicant
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact ED SHAUGHNESSY
Correspondent
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact ED SHAUGHNESSY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/23/1984
Decision Date 12/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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