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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 K133665
Device Name MALLEABLE SUCTION INSTRUMENTS
Applicant
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Applicant Contact CHARLES M COPPERBERG
Correspondent
MEDTRONIC NAVIGATION, INC.
826 COAL CREEK CIR.
LOUISVILLE,  CO  80027
Correspondent Contact CHARLES M COPPERBERG
Regulation Number882.4560
Classification Product Code
PGW  
Date Received11/29/2013
Decision Date 03/13/2014
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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