COCHLEAR BAHA BP100
FDA 510(k) clearance K090720 · decided 2009-06-17
Clearance details
- K-number
- K090720
- Device name
- COCHLEAR BAHA BP100
- Applicant
- Cochlear Bone Anchored Systems AB
- Decision
- Substantially Equivalent
- Date received
- 2009-03-18
- Decision date
- 2009-06-17
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Centennial, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.