
Cobe Renal Care, Inc.
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GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS is an FDA 510(k)-cleared medical device (K955487) manufactured by Cobe Renal Care, Inc.. 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 April 17, 1997. Regulation: 8.