NuVent EM Sinus Dilation System

Instrument, Ent Manual Surgical

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Nuvent Em Sinus Dilation System.

Pre-market Notification Details

Device IDK152121
510k NumberK152121
Device Name:NuVent EM Sinus Dilation System
ClassificationInstrument, Ent Manual Surgical
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville,  FL  32216
ContactGabriela Anchondo
CorrespondentGabriela Anchondo
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville,  FL  32216
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-30
Decision Date2015-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169770997 K152121 000
00643169705296 K152121 000
00643169705302 K152121 000
00643169770904 K152121 000
00643169770911 K152121 000
00643169770928 K152121 000
00643169770935 K152121 000
00643169770942 K152121 000
00643169770959 K152121 000
00643169770966 K152121 000
00643169770973 K152121 000
00643169770980 K152121 000
00643169705289 K152121 000

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