
U-Marc, Inc.
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CMR 300, ROWATER TREATMENT UNIT is an FDA 510(k)-cleared medical device (K802474) manufactured by U-Marc, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 1980. Regulation: 8.