Submission Details
| 510(k) Number | K053563 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 21, 2005 |
| Decision Date | April 07, 2006 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
K053563 - HUMAPEN MEMOIR
(FDA 510(k) Clearance)
Apr 2006
Decision
107d
Days
Class 2
Risk
K053563 is an FDA 510(k) clearance for the HUMAPEN MEMOIR, 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 April 7, 2006, 107 days after receiving the submission on December 21, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Similar Devices — FMF Syringe, Piston
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