Aqua Naina Sterile Saline Solution

Aqua Naina Sterile Saline Solution is an FDA 510(k)-cleared medical device (K193441) manufactured by Chemtex USA, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2020. Regulation: 8.