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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K153660
Device Name StealthStation System with Cranial Software
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUSVILLE,  CO  80027
Applicant Contact Augusta Henao
Correspondent
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUSVILLE,  CO  80027
Correspondent Contact Augusta Henao
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/21/2015
Decision Date 09/14/2016
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
Recalls CDRH Recalls
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