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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 K910100
Device Name ELECTONE BTE MODEL AM 130 D
Applicant
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Applicant Contact JIM NEE
Correspondent
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Correspondent Contact JIM NEE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/09/1991
Decision Date 01/29/1991
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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