MEROGEL NASAL DRESSING AND SINUS STENT

Balloon, Epistaxis

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Merogel Nasal Dressing And Sinus Stent.

Pre-market Notification Details

Device IDK982731
510k NumberK982731
Device Name:MEROGEL NASAL DRESSING AND SINUS STENT
ClassificationBalloon, Epistaxis
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactRoy Berens
CorrespondentRoy Berens
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeEMX  
CFR Regulation Number874.4100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-05
Decision Date1999-02-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033549790967 K982731 000
08033549790950 K982731 000
08033549790721 K982731 000
08033549790714 K982731 000
08033549791124 K982731 000
08033549791117 K982731 000

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