Clearance Summary
SAFE-T-CAP NEEDLE COVER received FDA 510(k) clearance under submission number K896219, sponsored by Ausmedics Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-01-22.
- Submission: K896219
- Applicant / Sponsor: Ausmedics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4730
- Decision date: 1990-01-22
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.