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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 K892457
Device Name TELSTAR MODEL 1/3 ITE HEARING AID
Applicant
TELSTAR ELECTRONICS, INC.
209 MOSS RD.
WINTER SPRINGS,  FL  32708
Applicant Contact KIM A FISHER
Correspondent
TELSTAR ELECTRONICS, INC.
209 MOSS RD.
WINTER SPRINGS,  FL  32708
Correspondent Contact KIM A FISHER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/10/1989
Decision Date 06/06/1989
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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