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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
Applicant
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Applicant Contact PIERRE VREULS
Correspondent
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Correspondent Contact PIERRE VREULS
Regulation Number874.1820
Classification Product Code
ETN  
Date Received04/26/2012
Decision Date 08/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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