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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 K844860
Device Name POST-AURICULAR HEARING AID MODEL PE 600CHD
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 Received12/14/1984
Decision Date 03/27/1985
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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