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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
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