Clearance Summary
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE received FDA 510(k) clearance under submission number K843314, sponsored by Smith & Nephew, Mpl Division. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-09-27.
- Submission: K843314
- Applicant / Sponsor: Smith & Nephew, Mpl Division
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 1984-09-27
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.