
Deka Research and Development
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HemoCare Hemodialysis System is an FDA 510(k)-cleared medical device (K233557) manufactured by Deka Research and Development. 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 11, 2024. Regulation: 8.