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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 K862773
Device Name PHONIC EAR, MODEL PE475R
Applicant
PHONIC EAR, INC.
250 CAMINO ALTO
MILL VALLEY,  CA  94941
Applicant Contact ROBERT L REINKE
Correspondent
PHONIC EAR, INC.
250 CAMINO ALTO
MILL VALLEY,  CA  94941
Correspondent Contact ROBERT L REINKE
Regulation Number874.3320
Classification Product Code
EPF  
Date Received07/22/1986
Decision Date 10/09/1986
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
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