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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 K926424
Device Name CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
Applicant
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Applicant Contact LINDA JALBERT
Correspondent
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Correspondent Contact LINDA JALBERT
Regulation Number882.1310
Classification Product Code
GYC  
Date Received12/23/1992
Decision Date 11/19/1993
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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