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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 K884871
Device Name RESOUND HES, DIGITALLY PROGR., ITE HEARING AID
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 Number874.3300
Classification Product Code
ESD  
Date Received11/21/1988
Decision Date 02/22/1989
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
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