MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM is an FDA 510(k)-cleared medical device (K012510) manufactured by Nxstage Medical, 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 October 18, 2001. Regulation: 8.