K111467 is an FDA 510(k) clearance for the FLEXI-Q DV AND DVR AUTO-INJECTORS. This device is classified as a Introducer, Syringe Needle (Class II - Special Controls, product code KZH).
Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on February 9, 2012, 259 days after receiving the submission on May 26, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6920.
| 510(k) Number | K111467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2011 |
| Decision Date | February 09, 2012 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KZH — Introducer, Syringe Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6920 |