K111091 is an FDA 510(k) clearance for the MERIT MEDICAL 20 ML SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 24, 2011, 66 days after receiving the submission on April 19, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K111091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2011 |
| Decision Date | June 24, 2011 |
| Days to Decision | 66 days |
| Submission Type | Special |
| 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 |