ULTRACELL SUCTION SPONGE

ULTRACELL SUCTION SPONGE is an FDA 510(k)-cleared medical device (K972633) manufactured by Ultracell Medical Technologies, 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 December 16, 1997. Regulation: 8.