TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET

TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET is an FDA 510(k)-cleared medical device (K953289) manufactured by Davis & Geck, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 1995. Regulation: 8.