BARRIER SAF-TE HYDROGEL DRAPE

BARRIER SAF-TE HYDROGEL DRAPE is an FDA 510(k)-cleared medical device (K922918) manufactured by Johnson & Johnson International. 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 July 5, 1993. Regulation: 8.