MR Syringe Dual Pack for Solaris Injectors

MR Syringe Dual Pack for Solaris Injectors is an FDA 510(k)-cleared medical device (K161471) manufactured by Coeur, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 5, 2016. Regulation: 8.