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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 K924226
Device Name OJEMANN CORTICAL STIMULATOR
Applicant
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
Applicant Contact LINDA JALBERT
Correspondent
RADIONICS, INC.
P.O. BOX 438
76 CAMBRIDGE STREET
BURLINGTON,  MA  01803 -0738
Correspondent Contact LINDA JALBERT
Regulation Number882.1310
Classification Product Code
GYC  
Date Received08/21/1992
Decision Date 04/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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