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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 -1876
Applicant Contact DAVID A PUTZ
Correspondent
AD-TECH MEDICAL INSTRUMENT CORP.
1901 WILLIAM ST.
RACINE,  WI  53404 -1876
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
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