
Fresenius Medical Care, North America - Renal Ther
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ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY is an FDA 510(k)-cleared medical device (K133299) manufactured by Fresenius Medical Care, North America - Renal Ther. 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 6, 2014. Regulation: 8.