Clearance Summary
MICRO-VENT received FDA 510(k) clearance under submission number K864321, sponsored by Core-Vent Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-01-07.
- Submission: K864321
- Applicant / Sponsor: Core-Vent Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1987-01-07
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.