A4-XLR8 FOAM DRESSING

A4-XLR8 FOAM DRESSING is an FDA 510(k)-cleared medical device (K092992) manufactured by Genadyne Biotechnologies, 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 June 28, 2010. Regulation: 8.