DM001 DISPOSABLE PACK

DM001 DISPOSABLE PACK is an FDA 510(k)-cleared medical device (K953539) manufactured by American Optisurgical, 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 25, 1995. Regulation: 8.