510(k) K982842

HUMAPEN AND HUMAPEN ERGO by Eli Lilly and Co. — Product Code FMF

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