The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit 10ml Syringe.
| Device ID | K142636 |
| 510k Number | K142636 |
| Device Name: | Merit 10mL Syringe |
| Classification | Syringe, Piston |
| Applicant | Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
| Contact | Mridi Kumathe |
| Correspondent | Mridi Kumathe Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2014-10-17 |
| Summary: | summary |