SECOND EAR BONE CONDUCTION HEARING AID
FDA 510(k) clearance K953872 · decided 1996-04-12
Clearance details
- K-number
- K953872
- Device name
- SECOND EAR BONE CONDUCTION HEARING AID
- Applicant
- Wordcomp International Communication Group (Wicg)
- Decision
- Substantially Equivalent
- Date received
- 1995-08-17
- Decision date
- 1996-04-12
- Days to decision
- 239 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
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.