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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 K974287
Device Name FM RECEIVER - AUDITORY TRAINER
Applicant
Phonic Ear, Inc.
3880 Cypress Dr.
Petaluma,  CA  94954
Applicant Contact ROBERT L REINKE
Correspondent
Phonic Ear, Inc.
3880 Cypress Dr.
Petaluma,  CA  94954
Correspondent Contact ROBERT L REINKE
Regulation Number874.3320
Classification Product Code
EPF  
Date Received11/14/1997
Decision Date 02/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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