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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 K163355
Device Name Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
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  
Date Received11/30/2016
Decision Date 04/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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