MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE

MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE is an FDA 510(k)-cleared medical device (K032777) manufactured by Nipro Medical Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 2003. Regulation: 8.