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 |