
Travenol Laboratories, S.A.
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HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 is an FDA 510(k)-cleared medical device (K872364) manufactured by Travenol Laboratories, S.A.. 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 October 12, 1987. Regulation: 8.