Cleared Traditional

HUMAPEN LUXURA HD

K100988 · Eli Lilly and Company · General Hospital
Aug 2010
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K100988 is an FDA 510(k) clearance for the HUMAPEN LUXURA HD, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on August 17, 2010, 130 days after receiving the submission on April 9, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K100988 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2010
Decision Date August 17, 2010
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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