INTERWOVEN(TM) REUSABLE SURGICAL GOWN

INTERWOVEN(TM) REUSABLE SURGICAL GOWN is an FDA 510(k)-cleared medical device (K945658) 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 March 21, 1995. Regulation: 8.