Clearance Summary
HUMAPEN LUXURA HD received FDA 510(k) clearance under submission number K063151, sponsored by Eli Lilly and Co.. 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 2007-01-09.
- Submission: K063151
- Applicant / Sponsor: Eli Lilly and Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2007-01-09
Classification & Regulation
This clearance is catalogued under FDA product code NSC and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.