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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 K153555
Device Name EM ENT Navigated Suctions
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Applicant Contact Carey Brenner
Correspondent
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Correspondent Contact Carey Brenner
Regulation Number882.4560
Classification Product Code
PGW  
Date Received12/14/2015
Decision Date 04/07/2016
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
Recalls CDRH Recalls
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