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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 K162309
Device Name StealthStation S8 System Platforms and StealthStation Cranial Software
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Applicant Contact Tia Fushimi-Bain
Correspondent
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Correspondent Contact Tia Fushimi-Bain
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Codes
OLO   PGW  
Date Received08/17/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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