LYRIC HEARING AID


Device Classification Name

hearing aid, air conduction

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

Correspodent Contact susan whichard
Regulation Number 874.3300
Classification Product Code
ESD  
Date Received 04/21/2008
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