
Fortune Medical Instrument Corp.
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ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR is an FDA 510(k)-cleared medical device (K980917) manufactured by Fortune Medical Instrument Corp.. 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 May 26, 1998. Regulation: 8.