
Merit Medical Systems, Inc.
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MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE is an FDA 510(k)-cleared medical device (K083523) manufactured by Merit Medical Systems, 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 February 3, 2009. Regulation: 8.