DEROYAL DRAPES, STERILE, NON-STERILE

DEROYAL DRAPES, STERILE, NON-STERILE is an FDA 510(k)-cleared medical device (K030365) manufactured by Deroyal Industries, Inc.. 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 April 28, 2003. Regulation: 8.