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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 K923234
Device Name PE 400IR, PE 400T, PE 400E
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 Received07/01/1992
Decision Date 09/29/1992
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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