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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 K960935
Device Name AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)
Applicant
Hearing Solutions, Inc.
1776 E. Lancaster Ave.
Paoli,  PA  19301
Applicant Contact EDOUARD A GAUTHIER
Correspondent
Hearing Solutions, Inc.
1776 E. Lancaster Ave.
Paoli,  PA  19301
Correspondent Contact EDOUARD A GAUTHIER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/08/1996
Decision Date 04/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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