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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K912669
Device Name RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
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 Number874.1050
Classification Product Code
EWO  
Date Received06/18/1991
Decision Date 09/16/1991
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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