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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 K962798
Device Name AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
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 Received07/18/1996
Decision Date 09/09/1996
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
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