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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 K133444
Device Name STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Applicant Contact KAYE WAITE
Correspondent
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Correspondent Contact KAYE WAITE
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received11/12/2013
Decision Date 07/25/2014
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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