510(k) K063151
K063151 is an FDA 510(k) premarket notification submitted by Eli Lilly and Co. for the device "HUMAPEN LUXURA HD". The FDA issued a decision of Substantially Equivalent on January 9, 2007. The device falls under product code NSC (Injector, Pen), a Class II device regulated under 21 CFR 880.5860. Eli Lilly and Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2007
- Date Received
- October 16, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Pen
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.