
Hospal Medical Corp.
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CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT is an FDA 510(k)-cleared medical device (K883307) manufactured by Hospal Medical 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 October 11, 1988. Regulation: 8.