The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Merit Syringe.
| Device ID | K182216 |
| 510k Number | K182216 |
| Device Name: | Merit Syringe |
| Classification | Syringe, Piston |
| Applicant | Merit Medical Systems, Inc 1600 W Merit Parkway South Jordan, UT 84095 |
| Contact | John Skousen |
| Correspondent | John Skousen 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2018-11-06 |
| Summary: | summary |