MR-5200 FULL DISCLOSURE SYSTEM

MR-5200 FULL DISCLOSURE SYSTEM is an FDA 510(k)-cleared medical device (K911257) 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 August 18, 1991. Regulation: 8.