K024052 is an FDA 510(k) clearance for the MERIT MEDICAL 1-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 February 21, 2003, 77 days after receiving the submission on December 6, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K024052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2002 |
| Decision Date | February 21, 2003 |
| Days to Decision | 77 days |
| Submission Type | Abbreviated |
| 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 |