ZARA CHIN IMPLANT
FDA 510(k) clearance K910456 · decided 1991-02-19
Clearance details
- K-number
- K910456
- Device name
- ZARA CHIN IMPLANT
- Applicant
- Byron Medical
- Decision
- Substantially Equivalent
- Date received
- 1991-02-04
- Decision date
- 1991-02-19
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.