APPALEAD GW+03XXXXXXR SERIES

APPALEAD GW+03XXXXXXR SERIES is an FDA 510(k)-cleared medical device (K003394) manufactured by Nipro Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2001. Regulation: 8.