FLO-GARD(R) 6200, 6300 & 8000

FLO-GARD(R) 6200, 6300 & 8000 is an FDA 510(k)-cleared medical device (K913895) manufactured by Baxter Healthcare 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 October 20, 1991. Regulation: 8.