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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Depth
510(k) Number K152547
Device Name DNAP Electrode
Applicant
Ad-Tech Medical Instrument Corporation
1901 William Street
Racine,  WI  53404
Applicant Contact Lisa Theama
Correspondent
QUALITY & REGULATORY ASSOCIATES, LLC.
800 LEVANGER LANE.
STOUGHTON,  WI  53589
Correspondent Contact Gary J Syring
Regulation Number882.1330
Classification Product Code
GZL  
Subsequent Product Code
GYC  
Date Received09/08/2015
Decision Date 03/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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