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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K123163
Device Name NEUROPACE BURR HOLE COVER MODEL 8110
Applicant
Neuropace, Inc.
455 N Bernardo Ave.
Mountaint View,  CA  94043
Applicant Contact ISABELLA ABATI
Correspondent
Neuropace, Inc.
455 N Bernardo Ave.
Mountaint View,  CA  94043
Correspondent Contact ISABELLA ABATI
Regulation Number882.5250
Classification Product Code
GXR  
Date Received10/09/2012
Decision Date 01/18/2013
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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