FDA.report

510(k) K173601

Device
Merit Syringe
Applicant
Merit Medical Systems, Inc.
510(k) number
K173601
Product code
FMF  
Decision
Substantially Equivalent (SESE)
Decision date
2018-01-31
Date received
2017-11-21
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Cory Marsh
Address
1600 W Merit Pkwy. South Jordan UT US 84045 84045

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases