STERILESERT(TM) CABLE AND POLE DRAPE

STERILESERT(TM) CABLE AND POLE DRAPE is an FDA 510(k)-cleared medical device (K913047) manufactured by Arch Development Group. 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 October 1, 1991. Regulation: 8.