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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K984518
Device Name SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
Applicant
SONIC INNOVATIONS, INC.
5330 SOUTH 900 EAST, SUITE 240
SALT LAKE CITY,  UT  84117
Applicant Contact JEANNETTE S JOHNSON
Correspondent
SONIC INNOVATIONS, INC.
5330 SOUTH 900 EAST, SUITE 240
SALT LAKE CITY,  UT  84117
Correspondent Contact JEANNETTE S JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/21/1998
Decision Date 03/12/1999
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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