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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 K931023
Device Name IN-THE-EAR HEARING AID
Applicant
HEARING IMPROVEMENT
2929 WASHINGTON BLVD.
OGDEN,  UT  84401
Applicant Contact ROSS WESTERN
Correspondent
HEARING IMPROVEMENT
2929 WASHINGTON BLVD.
OGDEN,  UT  84401
Correspondent Contact ROSS WESTERN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/01/1993
Decision Date 05/05/1993
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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