Clearance Summary
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST received FDA 510(k) clearance under submission number K833304, 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 1984-03-30.
- Submission: K833304
- Applicant / Sponsor: Smith & Nephew, Mpl Division
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4730
- Decision date: 1984-03-30
Classification & Regulation
This clearance is catalogued under FDA product code DZM and 21 CFR 872.4730, within the Dental review panel as a Class I device.