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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K932691
Device Name PROTECTRODE SYSTEMS CONCENTRIC
Applicant
The Electrode Store, Inc.
240 Auburn Way S.,
P.O. Box 188
Enumclaw,  WA  98022
Applicant Contact TIMOTHY S COOKE
Correspondent
The Electrode Store, Inc.
240 Auburn Way S.,
P.O. Box 188
Enumclaw,  WA  98022
Correspondent Contact TIMOTHY S COOKE
Regulation Number890.1385
Classification Product Code
IKT  
Date Received06/02/1993
Decision Date 11/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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