Clearance Summary
MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM received FDA 510(k) clearance under submission number K943345, sponsored by Patton, Boggs & Blow. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-10-04.
- Submission: K943345
- Applicant / Sponsor: Patton, Boggs & Blow
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 1994-10-04
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.