0.55% ORTH-PHTHALALDEHYDE SOLUTION

0.55% ORTH-PHTHALALDEHYDE SOLUTION is an FDA 510(k)-cleared medical device (K030004) manufactured by Advanced Sterilization Products. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2003. Regulation: 8.