The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Medical 1-ml Syringe.
| Device ID | K024052 |
| 510k Number | K024052 |
| Device Name: | MERIT MEDICAL 1-ML SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Stephanie A Erskine |
| Correspondent | Stephanie A Erskine 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-06 |
| Decision Date | 2003-02-21 |
| Summary: | summary |