KLARITY VACUUM BAG, KLARITY MOLD CUSHION

KLARITY VACUUM BAG, KLARITY MOLD CUSHION is an FDA 510(k)-cleared medical device (K132124) manufactured by Klarity Medical Products, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 2013. Regulation: 8.