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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 K082629
Device Name S12X WITH ESAX OPTION
Applicant
CHATTEN ASSOCIATES, INC.
1094 NEW DEHAVEN AVE
SUITE 200
WEST CONSHOHOCKEN,  PA  19428
Applicant Contact JOHN B CHATTEN
Correspondent
CHATTEN ASSOCIATES, INC.
1094 NEW DEHAVEN AVE
SUITE 200
WEST CONSHOHOCKEN,  PA  19428
Correspondent Contact JOHN B CHATTEN
Regulation Number882.1310
Classification Product Code
GYC  
Date Received09/09/2008
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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