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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 K860007
Device Name AM 12, HEARING AID
Applicant
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Applicant Contact MICHAEL D UNDERHILL
Correspondent
ELECTONE, INC.
P.O. BOX 910
WINTER PARK,  FL  32790
Correspondent Contact MICHAEL D UNDERHILL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/03/1986
Decision Date 03/12/1986
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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