Clearance Summary
MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER received FDA 510(k) clearance under submission number K903007, sponsored by Habley Medical Technology 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 1990-09-19.
- Submission: K903007
- Applicant / Sponsor: Habley Medical Technology Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 1990-09-19
Classification & Regulation
This clearance is catalogued under FDA product code EJI and 21 CFR 872.6770, within the Dental review panel as a Class II device.