SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE is an FDA 510(k)-cleared medical device (K011105) manufactured by Qrc Consulting. 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 29, 2001. Regulation: 8.