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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 K912665
Device Name SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
Applicant
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Applicant Contact JEANNETTE JOHNSON
Correspondent
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Correspondent Contact JEANNETTE JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/18/1991
Decision Date 07/24/1991
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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