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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 K013253
Device Name HISONIC-TRD TINNITUS RELIEF DEVICE
Applicant
Hearing Innovations, Inc.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact GERARD J PRUD'HOMME
Correspondent
Hearing Innovations, Inc.
Columbia Square
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number874.3400
Classification Product Code
KLW  
Date Received09/28/2001
Decision Date 04/05/2002
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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