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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 K914899
Device Name SONOTONE BEHIND THE EAR MODEL ST 45G
Applicant
SONOTONE HEARING INSTRUMENTS
500 CHARLOTTE ST.
LONGWOOD,  FL  32750
Applicant Contact GLENN L KENNEDY
Correspondent
SONOTONE HEARING INSTRUMENTS
500 CHARLOTTE ST.
LONGWOOD,  FL  32750
Correspondent Contact GLENN L KENNEDY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/31/1991
Decision Date 01/09/1992
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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