XLR8 Abdominal Wound Dressing Kit

XLR8 Abdominal Wound Dressing Kit is an FDA 510(k)-cleared medical device (K182722) manufactured by Genadyne Biotechnologies. 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 September 26, 2019. Regulation: 8.