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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 K141833
Device Name STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
Applicant
MEDTRONIC NAVIGATION, INC.
826 Coal Creek Circle
Louisville,  CO  80027
Applicant Contact CHRISTOPHER PERMAN
Correspondent
MEDTRONIC NAVIGATION, INC.
826 Coal Creek Circle
Louisville,  CO  80027
Correspondent Contact CHRISTOPHER PERMAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/07/2014
Decision Date 03/25/2015
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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