The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Monarch Compak Inflation Syringe And Universal Fluid Dispensing Syringe.
| Device ID | K083523 |
| 510k Number | K083523 |
| Device Name: | MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Susan D Scott |
| Correspondent | Susan D Scott MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-02-04 |
| Summary: | summary |