510(k) K982842
K982842 is an FDA 510(k) premarket notification submitted by Eli Lilly and Co. for the device "HUMAPEN AND HUMAPEN ERGO". The FDA issued a decision of Substantially Equivalent on September 25, 1998. The device falls under product code FMF (Syringe, Piston), 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
- September 25, 1998
- Date Received
- August 12, 1998
- 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