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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, Air-Conduction, Prescription
510(k) Number K864672
Device Name PHONIC EAR MODELS PE 811CS AND PE 811CST
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 Number874.3300
Classification Product Code
ESD  
Date Received12/02/1986
Decision Date 02/20/1987
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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