510(k) K160668
K160668 is an FDA 510(k) premarket notification submitted by Eli Lilly And Company, Inc. for the device "HumaPen Savvio". The FDA issued a decision of Substantially Equivalent on Jun 3, 2016. 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
- Jun 3, 2016
- Date Received
- Mar 9, 2016
- 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)