MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND

MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND is an FDA 510(k)-cleared medical device (K942072) manufactured by Mabis Healthcare, 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 9, 1995. Regulation: 8.