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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 K223269
Device Name Spencer Probe Depth Electrodes
Applicant
Ad-Tech Medical Instrument Corporation
400 W Oakview Pkwy
Oak Creek,  WI  53154 -7213
Applicant Contact Brendan McCrea
Correspondent
NAMSA
400 Highway 169 South
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Marcella Martin
Regulation Number882.1330
Classification Product Code
GZL  
Date Received10/24/2022
Decision Date 05/18/2023
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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