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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 K880184
Device Name VIBRASOUND IN-THE-EAR HEARING AID
Applicant
VIBRASOUND RESEARCH CORP.
2855 WEST OXFORD AVE., #4
ENGLEWOOD,  CO  80110
Applicant Contact KUHN, PHD
Correspondent
VIBRASOUND RESEARCH CORP.
2855 WEST OXFORD AVE., #4
ENGLEWOOD,  CO  80110
Correspondent Contact KUHN, PHD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/15/1988
Decision Date 03/09/1988
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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