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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 K843921
Device Name IN THE CANAL HEARING AID RC, REDICANAL
Applicant
OMNI HEARING SYSTEMS
P.O. BOX 115008
CARROLTON,  TX  75006
Applicant Contact JORGEN HEIDE
Correspondent
OMNI HEARING SYSTEMS
P.O. BOX 115008
CARROLTON,  TX  75006
Correspondent Contact JORGEN HEIDE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/05/1984
Decision Date 11/01/1984
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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