Clearance Summary
MED-E-JET INJECTOR received FDA 510(k) clearance under submission number K913018, sponsored by Med-E-Jet D. 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 1991-09-16.
- Submission: K913018
- Applicant / Sponsor: Med-E-Jet D
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5430
- Decision date: 1991-09-16
Classification & Regulation
This clearance is catalogued under FDA product code KZE and 21 CFR 880.5430, within the General Hospital review panel as a Class II device.