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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 K882633
Device Name ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
Applicant
Ensoniq Corp.
155 Greay Valley Pkwy.
Malvern,  PA  19355
Applicant Contact EDOUARD A GAUTHIER
Correspondent
Ensoniq Corp.
155 Greay Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact EDOUARD A GAUTHIER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/27/1988
Decision Date 01/13/1989
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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