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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 K860512
Device Name TELESTAR I, HEARING AID
Applicant
THE FLORIDA HEARING AID SERVICE
P.O. BOX 309
CASSELBERRRY,  FL  32707
Applicant Contact CHARI
Correspondent
THE FLORIDA HEARING AID SERVICE
P.O. BOX 309
CASSELBERRRY,  FL  32707
Correspondent Contact CHARI
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/11/1986
Decision Date 03/17/1986
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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