
Fresenius Pharma
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ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE is an FDA 510(k)-cleared medical device (K901134) manufactured by Fresenius Pharma. 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 June 19, 1990. Regulation: 8.