The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte System Bone Plate.
Device ID | K023360 |
510k Number | K023360 |
Device Name: | LEFORTE SYSTEM BONE PLATE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
Applicant | JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled, IL 60015 |
Product Code | KTW |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-07 |
Decision Date | 2002-10-25 |
Summary: | summary |