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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 K843980
Device Name PERSONAL AMPLIFIER SILENCER
Applicant
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Applicant Contact CHARI
Correspondent
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Correspondent Contact CHARI
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/11/1984
Decision Date 11/16/1984
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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