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510(k) K082629

S12X WITH ESAX OPTION by Chatten Associates, Inc. — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2009
Date Received
September 9, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

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