
Asahi Medical Co., Ltd.
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ASAHI HOLLOW FIBER KIDNEYS, EXCEL is an FDA 510(k)-cleared medical device (K833150) manufactured by Asahi Medical Co., Ltd.. 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 November 14, 1983. Regulation: 8.