FRONTAL SINUS TREPHINATION CANNULA

Cannula, Sinus

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Frontal Sinus Trephination Cannula.

Pre-market Notification Details

Device IDK994262
510k NumberK994262
Device Name:FRONTAL SINUS TREPHINATION CANNULA
ClassificationCannula, Sinus
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactMartin D Sargent
CorrespondentMartin D Sargent
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeKAM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-17
Decision Date2000-02-08
Summary:summary

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