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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
510(k) Number K926094
Device Name PROTECTRODE SYSTEM
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 Number882.1350
Classification Product Code
GXZ  
Date Received12/02/1992
Decision Date 12/06/1995
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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