MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT

Splint, Intranasal Septal

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Meropack Bioresorbable Nasal Packing And Sinus Stent.

Pre-market Notification Details

Device IDK041381
510k NumberK041381
Device Name:MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
ClassificationSplint, Intranasal Septal
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactDavid S Dodd
CorrespondentDavid S Dodd
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeLYA  
CFR Regulation Number874.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-25
Decision Date2004-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20885074137791 K041381 000
20885074137777 K041381 000

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