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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, Master
510(k) Number K894019
Device Name RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
Applicant
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY,  CA  94063
Applicant Contact VINCENT PLUVINAGE
Correspondent
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY,  CA  94063
Correspondent Contact VINCENT PLUVINAGE
Regulation Number874.3330
Classification Product Code
KHL  
Date Received06/06/1989
Decision Date 09/21/1989
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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