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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 K223276
Device Name Anchor Bolts as Accessories to Depth Electrodes
Applicant
Ad-Tech Medical Instrument Corporation
400 W. Oakview Pkwy.
Oak Creek,  WI  53154
Applicant Contact Brendan McCrea
Correspondent
Namsa Medical Research Organization
400 Hwy. 169 S.
Suite 500
Minneapolis,  MN  55426
Correspondent Contact Linford Leitch
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
Predetermined Change
Control Plan Authorized		 No
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