The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Syringe.
Device ID | K182279 |
510k Number | K182279 |
Device Name: | Merit Syringe |
Classification | Syringe, Piston |
Applicant | Merit Medical Systems, Inc. 1600W Merit Parkway South Jordan, UT 84095 |
Contact | John Skousen |
Correspondent | John Skousen Merit Medical Systems, Inc. 1600W Merit Parkway South Jordan, UT 84095 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-22 |
Decision Date | 2018-11-06 |
Summary: | summary |