Clearance Summary
SIMPLEX AIRBRATOR received FDA 510(k) clearance under submission number K970249, sponsored by Simplex Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-05-07.
- Submission: K970249
- Applicant / Sponsor: Simplex Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6080
- Decision date: 1997-05-07
Classification & Regulation
This clearance is catalogued under FDA product code KOJ and 21 CFR 872.6080, within the Dental review panel as a Class II device.