510(k) K151686
K151686 is an FDA 510(k) premarket notification submitted by Eli Lilly And Company, Inc. for the device "HumanPen Ergo II". The FDA issued a decision of Substantially Equivalent on Dec 30, 2015. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Eli Lilly And Company, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 30, 2015
- Date Received
- Jun 23, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)