The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Monarch(tm) Inflation Syringe.
| Device ID | K913994 |
| 510k Number | K913994 |
| Device Name: | MONARCH(TM) INFLATION SYRINGE |
| Classification | Syringe, Balloon Inflation |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
| Contact | Dennis Reigle |
| Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1992-02-04 |