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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve
510(k) Number K112686
Device Name NEXT GEN EMG ENDOTRACHEAL TUBE
Original Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville,  FL  32216
Original Contact marek pawlowski
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/15/2011
Decision Date 06/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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