CONVERTORS ISO BAC DRAPE MATERIAL

CONVERTORS ISO BAC DRAPE MATERIAL is an FDA 510(k)-cleared medical device (K931267) manufactured by Baxter Healthcare Corp. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 1994. Regulation: 8.