Device Classification Name |
hearing aid, bone conduction, implanted |
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---|---|---|---|---|
510(k) Number | K121317 | |||
Device Name | COCHLEAR BAHA IMPLANT SYSTEM | |||
Applicant |
|
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Applicant Contact | sean bundy | |||
Correspondent |
|
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Correspodent Contact | sean bundy | |||
Regulation Number | 874.3300 | |||
Classification Product Code |
|
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Date Received | 05/02/2012 | |||
Decision Date | 10/12/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Ear Nose & Throat |
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510k Review Panel |
Ear Nose & Throat |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |