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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K033645
Device Name OTOFLEX 100 TYE 1012
Applicant
Gn Otometrics A/S
Dybendalsvaenget 2
P.O. Box 119
Taastrup,  DK DK-2630
Applicant Contact PER PAPE THOMSEN
Correspondent
Gn Otometrics A/S
Dybendalsvaenget 2
P.O. Box 119
Taastrup,  DK DK-2630
Correspondent Contact PER PAPE THOMSEN
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/20/2003
Decision Date 03/31/2004
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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