
Repro-Med Systems, Inc. Dba Koru Medical Systems
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FREEDOM Integrated Syringe Infusion System is an FDA 510(k)-cleared medical device (K200176) manufactured by Repro-Med Systems, Inc. Dba Koru Medical Systems. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2021. Regulation: 8.

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