The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte System Bone Plate.
| Device ID | K091679 |
| 510k Number | K091679 |
| Device Name: | LEFORTE SYSTEM BONE PLATE |
| Classification | Plate, Bone |
| Applicant | JEIL MEDICAL CORPORATION 215 S. STATE STREET STE: 100B Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo JEIL MEDICAL CORPORATION 215 S. STATE STREET STE: 100B Salt Lake City, UT 84111 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-10-02 |
| Summary: | summary |