POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367

POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 is an FDA 510(k)-cleared medical device (K964456) manufactured by Medtronic Minimed. 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 January 29, 1997. Regulation: 8.