
Fresenius USA, Inc.
Free shipping on orders over $99 · 30-day returns
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING is an FDA 510(k)-cleared medical device (K911459) manufactured by Fresenius USA, 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 July 16, 1991. Regulation: 8.