BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
FDA 510(k) clearance K992872 · decided 1999-11-24
Clearance details
- K-number
- K992872
- Device name
- BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
- Applicant
- Entific Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-26
- Decision date
- 1999-11-24
- Days to decision
- 90 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
- Skokie, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.