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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 K861031
Device Name WYLER SPHENOIDAL ELECTRODE
Applicant
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Applicant Contact DAVID PUTZ
Correspondent
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Correspondent Contact DAVID PUTZ
Regulation Number882.1330
Classification Product Code
GZL  
Date Received03/18/1986
Decision Date 08/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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