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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 K973846
Device Name AIR CONDUCTION HEARING AID
Applicant
BARON TRADING, INC.
22305 DUNMORE DR.
CALABASAS,  CA  91302
Applicant Contact PHILLIP RECHISTER
Correspondent
BARON TRADING, INC.
22305 DUNMORE DR.
CALABASAS,  CA  91302
Correspondent Contact PHILLIP RECHISTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/08/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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