The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Monarch Ap(tm).
Device ID | K943597 |
510k Number | K943597 |
Device Name: | MONARCH AP(TM) |
Classification | Syringe, Balloon Inflation |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Dennis Reigle |
Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Product Code | MAV |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-23 |
Decision Date | 1995-02-10 |