K100988 is an FDA 510(k) clearance for the HUMAPEN LUXURA HD. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K100988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |