HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) is an FDA 510(k)-cleared medical device (K063498) manufactured by Sebia. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2007. Regulation: 8.