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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 K845035
Device Name ELECTRODE FOR NEUROLOGICAL SURGERY 2111
Applicant
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Applicant Contact ALFRED A IVERSEN
Correspondent
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Correspondent Contact ALFRED A IVERSEN
Regulation Number882.1310
Classification Product Code
GYC  
Date Received12/27/1984
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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