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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 K874735
Device Name DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
Applicant
Dantec Electronics, Inc.
6 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact HENRIK HENRIKSEN
Correspondent
Dantec Electronics, Inc.
6 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact HENRIK HENRIKSEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received11/18/1987
Decision Date 01/22/1988
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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