The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Fluid Administration Set - Contrast Manager.
| Device ID | K961794 |
| 510k Number | K961794 |
| Device Name: | FLUID ADMINISTRATION SET - CONTRAST MANAGER |
| Classification | Set, Administration, Intravascular |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Dennis (dan) Reigle |
| Correspondent | Dennis (dan) Reigle MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-08-01 |
| Summary: | summary |