RS OPTIGUARD GOWN & DRAPE MATERIAL

RS OPTIGUARD GOWN & DRAPE MATERIAL is an FDA 510(k)-cleared medical device (K925715) 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 May 10, 1993. Regulation: 8.