MEDTRONIC XOMED, INC.

Device, Anti-snoring

MEDTRONIC XOMED, INC.

The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Medtronic Xomed, Inc..

Pre-market Notification Details

Device IDK122391
510k NumberK122391
Device Name:MEDTRONIC XOMED, INC.
ClassificationDevice, Anti-snoring
Applicant MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
ContactDouglas Johnson
CorrespondentDouglas Johnson
MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-07
Decision Date2013-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169523272 K122391 000
00643169523265 K122391 000
00763000089757 K122391 000

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