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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 K944980
Device Name SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM)
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 Received10/11/1994
Decision Date 01/18/1995
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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