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