The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Medical 20 Ml Syringe.
| Device ID | K111091 |
| 510k Number | K111091 |
| Device Name: | MERIT MEDICAL 20 ML SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. 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 | 2011-04-19 |
| Decision Date | 2011-06-24 |
| Summary: | summary |