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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K153247
Device Name Fusion Compact Navigation System
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Applicant Contact RISHI SINHA
Correspondent
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Correspondent Contact RISHI SINHA
Regulation Number882.4560
Classification Product Code
PGW  
Date Received11/09/2015
Decision Date 02/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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