COCHLEAR BAHA IMPLANT SYSTEM

Device Classification Name

hearing aid, bone conduction, implanted

510(k) Number K121317
Device Name COCHLEAR BAHA IMPLANT SYSTEM
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
MAH  
Date Received 05/02/2012
Decision Date 10/12/2012
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