Clearance Summary
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) received FDA 510(k) clearance under submission number K951005, sponsored by Kenex , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-05-04.
- Submission: K951005
- Applicant / Sponsor: Kenex , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1995-05-04
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.