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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cortical
510(k) Number K053363
Device Name DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
Applicant
AD-TECH MEDICAL INSTRUMENT CORP.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
AD-TECH MEDICAL INSTRUMENT CORP.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1310
Classification Product Code
GYC  
Date Received12/02/2005
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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