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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, hearing aid / earphone and analysis systems
510(k) Number K110286
Device Name GN OTOMETRICS TYPE 1053 FREEFIT
Applicant
GN OTOMETRICS A/S
125 COMMERCE DRIVE
SCHAUMBURG,  IL  60173 -5329
Applicant Contact TOM RINIKER
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number874.3310
Classification Product Code
ETW  
Date Received01/31/2011
Decision Date 04/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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