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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 K912760
Device Name AD-TECH EPIDURAL PEG 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 Number882.1310
Classification Product Code
GYC  
Date Received06/24/1991
Decision Date 01/15/1992
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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