
Fortune Medical Instrument Corp.
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ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER is an FDA 510(k)-cleared medical device (K980919) 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 March 30, 1998. Regulation: 8.