EM ENT Navigated Suctions

Ear, Nose, And Throat Stereotaxic Instrument

MEDTRONIC NAVIGATION, INC.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Em Ent Navigated Suctions.

Pre-market Notification Details

Device IDK153555
510k NumberK153555
Device Name:EM ENT Navigated Suctions
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville,  CO  80027
ContactCarey Brenner
CorrespondentCarey Brenner
MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville,  CO  80027
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-14
Decision Date2016-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169702905 K153555 000
00763000054120 K153555 000
00763000054144 K153555 000
00763000053369 K153555 000
00763000053383 K153555 000
00763000053390 K153555 000
00643169702851 K153555 000
00643169702868 K153555 000
00643169702875 K153555 000
00643169702882 K153555 000
00643169702899 K153555 000
00763000054137 K153555 000

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