MALLEABLE SUCTION INSTRUMENTS

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 Malleable Suction Instruments.

Pre-market Notification Details

Device IDK133665
510k NumberK133665
Device Name:MALLEABLE SUCTION INSTRUMENTS
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville,  CO  80027
ContactCharles M Copperberg
CorrespondentCharles M Copperberg
MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIR. Louisville,  CO  80027
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-29
Decision Date2014-03-13
Summary:summary

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