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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 K970687
Device Name WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
Applicant
Williams Sound, LLC
10300 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact PAUL INGEBRIGTSEN
Correspondent
Williams Sound, LLC
10300 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact PAUL INGEBRIGTSEN
Regulation Number874.3320
Classification Product Code
EPF  
Date Received02/24/1997
Decision Date 05/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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