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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 K903427
Device Name NORTECH MODEL 86901000 ELECTRODE
Applicant
Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01830
Applicant Contact JANICE M PEVIDE
Correspondent
Andover Medical, Inc.
60 Newark St.
Haverhill,  MA  01830
Correspondent Contact JANICE M PEVIDE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/31/1990
Decision Date 08/17/1990
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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