HORIZON 2000/S 266-XXX-XXX

HORIZON 2000/S 266-XXX-XXX is an FDA 510(k)-cleared medical device (K880595) manufactured by Mennen Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 1988. Regulation: 8.