INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL

INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL is an FDA 510(k)-cleared medical device (K944138) 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 December 19, 1994. Regulation: 8.