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 Em Sinus Dilation System.

Pre-market Notification Details

Device IDK132297
510k NumberK132297
Device Name:EM SINUS DILATION SYSTEM
ClassificationInstrument, Ent Manual Surgical
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactRozanne Paciej
CorrespondentRozanne Paciej
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-24
Decision Date2013-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169434837 K132297 000
00643169420410 K132297 000
00643169420427 K132297 000
00643169420434 K132297 000
00643169420441 K132297 000
00643169420458 K132297 000
00643169420465 K132297 000
00643169420472 K132297 000
00643169420489 K132297 000
00643169420403 K132297 000

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