Clearance Summary
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE received FDA 510(k) clearance under submission number K972047, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-06-24.
- Submission: K972047
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 1997-06-24
Classification & Regulation
This clearance is catalogued under FDA product code MQN and 21 CFR 872.4760, within the Dental review panel as a Class II device.