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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
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