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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 S. 900 E., Suite 240
Salt Lake City,  UT  84117
Applicant Contact JEANNETTE S JOHNSON
Correspondent
Sonic Innovations, Inc.
5330 S. 900 E., 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
Predetermined Change
Control Plan Authorized		 No
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