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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 K053358
Device Name DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH 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 Number882.1330
Classification Product Code
GZL  
Date Received12/02/2005
Decision Date 05/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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