
Mediflex Intl.
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HEMODIALYSIS TRANSDUCER PROTECTOR is an FDA 510(k)-cleared medical device (K900841) manufactured by Mediflex Intl.. 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 14, 1990. Regulation: 8.