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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, anti-snoring
510(k) Number K122391
Model 76353200M
Device Name MEDTRONIC XOMED, INC.
Original Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville,  FL  32216
Original Contact douglas johnson
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/07/2012
Decision Date 01/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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