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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, Group And Auditory Trainer
510(k) Number K922570
Device Name RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1
Applicant
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Applicant Contact JEANNETTE S JOHNSON
Correspondent
Resound Corp.
220 Saginaw Dr.,
Seaport Centre
Redwood City,  CA  94063
Correspondent Contact JEANNETTE S JOHNSON
Regulation Number874.3320
Classification Product Code
EPF  
Date Received06/01/1992
Decision Date 08/06/1992
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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