LEFORTE SYSTEM BONE PLATE
FDA 510(k) clearance K091679 · decided 2009-10-02
Clearance details
- K-number
- K091679
- Device name
- LEFORTE SYSTEM BONE PLATE
- Applicant
- Jeil Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-06-09
- Decision date
- 2009-10-02
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.