Clearance Summary
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM received FDA 510(k) clearance under submission number K991294, sponsored by Medi-Ject Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-04-23.
- Submission: K991294
- Applicant / Sponsor: Medi-Ject Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5430
- Decision date: 1999-04-23
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.