BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT

BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT is an FDA 510(k)-cleared medical device (K963203) manufactured by Baxter Healthcare 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 24, 1997. Regulation: 8.