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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 K850123
Device Name IN-TH-EAR HEARING AID
Applicant
GENERAL HEARING INSTRUMENTS, INC.
2622 MALLARD DRIVE SW
ROANOKE,  VA  24018
Applicant Contact ROGER P JUNEAU
Correspondent
GENERAL HEARING INSTRUMENTS, INC.
2622 MALLARD DRIVE SW
ROANOKE,  VA  24018
Correspondent Contact ROGER P JUNEAU
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/14/1985
Decision Date 03/21/1985
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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