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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 K872556
Device Name HEARING AID M35/M36 SERIES
Applicant
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Applicant Contact FRED A WILSON
Correspondent
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Correspondent Contact FRED A WILSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/29/1987
Decision Date 07/16/1987
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
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