Clearance Summary
ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN received FDA 510(k) clearance under submission number K851903, sponsored by Astra Pharmaceutical Products, 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 1985-07-02.
- Submission: K851903
- Applicant / Sponsor: Astra Pharmaceutical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 1985-07-02
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.