Clearance Summary
ORAL STEEL CARTRIDGE SYRINGE received FDA 510(k) clearance under submission number K941915, sponsored by Robert W. Bauer & Assoc., 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 1995-01-26.
- Submission: K941915
- Applicant / Sponsor: Robert W. Bauer & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 1995-01-26
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.