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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 K850342
Device Name WYLER SUBDURAL STRIP ELECTRODE
Applicant
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Applicant Contact DAVID A PUTZ
Correspondent
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Correspondent Contact DAVID A PUTZ
Regulation Number882.1310
Classification Product Code
GYC  
Date Received01/28/1985
Decision Date 07/30/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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