ALAR Nasal Valve Stent

Suture, Nonabsorbable, Synthetic, Polyethylene

MEDTRONIC XOMED INC.

The following data is part of a premarket notification filed by Medtronic Xomed Inc. with the FDA for Alar Nasal Valve Stent.

Pre-market Notification Details

Device IDK151758
510k NumberK151758
Device Name:ALAR Nasal Valve Stent
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
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 CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-29
Decision Date2015-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169700899 K151758 000
20763000038186 K151758 000
20643169232000 K151758 000

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