BAHA 3 POWER SOUND PROCESSOR


Device Classification Name

hearing aid, bone conduction

510(k) Number K110996
Device Name BAHA 3 POWER SOUND PROCESSOR
Applicant
COCHLEAR AMERICAS
13059 e. peakview ave
centennial, 
CO 
80111

Applicant Contact sean bundy
Correspondent
COCHLEAR AMERICAS
13059 e. peakview ave
centennial, 
CO 
80111

Correspodent Contact sean bundy
Regulation Number 874.3300
Classification Product Code
LXB  
Date Received 04/11/2011
Decision Date 05/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No