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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 K961942
Device Name EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
Applicant
RADIONICS, INC.
P.O. BOX 438
22 TERRY AVENUE
BURLINGTON,  MA  01803 -2591
Applicant Contact AMY J LAFORTE
Correspondent
RADIONICS, INC.
P.O. BOX 438
22 TERRY AVENUE
BURLINGTON,  MA  01803 -2591
Correspondent Contact AMY J LAFORTE
Regulation Number882.1310
Classification Product Code
GYC  
Subsequent Product Code
GZL  
Date Received05/20/1996
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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