510(k) K150965
K150965 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "LeForte System II". The FDA issued a decision of Substantially Equivalent on Sep 17, 2015. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 17, 2015
- Date Received
- Apr 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type
- 510(k)