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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 K121257
Device Name LARYNGEAL ELECTRODE
Original Applicant
TECHNOMED EUROPE
amerikalaan 71
maastricht airport,  NL 6199 ae
Original Contact pierre vreuls
Regulation Number874.1820
Classification Product Code
ETN  
Date Received04/26/2012
Decision Date 08/28/2012
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
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