POLYFIN EXTENSION SET, MODELS 126 AND 128

POLYFIN EXTENSION SET, MODELS 126 AND 128 is an FDA 510(k)-cleared medical device (K965208) 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 February 25, 1997. Regulation: 8.