The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit 20 Ml Syringe.
Device ID | K152783 |
510k Number | K152783 |
Device Name: | Merit 20 ML Syringe |
Classification | Syringe, Piston |
Applicant | Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
Contact | Cory Marsh |
Correspondent | Cory Marsh Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84095 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-25 |
Decision Date | 2015-12-07 |
Summary: | summary |