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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 K081136
Device Name LYRIC HEARING AID
Applicant
INSOUND MEDICAL INC.
39660 EUREKA DRIVE
NEWARK,  CA  94560
Applicant Contact SUSAN WHICHARD
Correspondent
INSOUND MEDICAL INC.
39660 EUREKA DRIVE
NEWARK,  CA  94560
Correspondent Contact SUSAN WHICHARD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/21/2008
Decision Date 05/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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