
National Medical Care, Medical Products Div., Inc.
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DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET is an FDA 510(k)-cleared medical device (K920586) manufactured by National Medical Care, Medical Products Div., 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 September 20, 1992. Regulation: 8.