Clearance Summary
E.N.S.I. SYRINGE received FDA 510(k) clearance under submission number K000572, sponsored by Tri-Ject Intl. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-02-24.
- Submission: K000572
- Applicant / Sponsor: Tri-Ject Intl. Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2000-02-24
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.