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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K073636
Device Name TINNITUS SOUND GENERATOR MODULE
Applicant
Gn Resound A/S
Lautrupbjerg 7
Ballerup,  DK DK-2750
Applicant Contact LARS HAGANDER
Correspondent
Gn Resound A/S
Lautrupbjerg 7
Ballerup,  DK DK-2750
Correspondent Contact LARS HAGANDER
Regulation Number874.3400
Classification Product Code
KLW  
Date Received12/26/2007
Decision Date 03/13/2008
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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