510(k) K043297
K043297 is an FDA 510(k) premarket notification submitted by Medicon EG for the device "MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 23, 2005. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Medicon EG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2005
- Date Received
- November 29, 2004
- Clearance Type
- Special
- 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