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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 K923293
Device Name ITC HEARING AID CLUB MODEL LM50H
Applicant
Club Hearing Instruments A/S
Tuborg Havnevej 1
Hellerup
Denmark, 2900,  DK
Applicant Contact ERIK RASMUSSEN
Correspondent
Club Hearing Instruments A/S
Tuborg Havnevej 1
Hellerup
Denmark, 2900,  DK
Correspondent Contact ERIK RASMUSSEN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/02/1992
Decision Date 09/23/1992
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
Predetermined Change
Control Plan Authorized		 No
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