SYSTEM U3 FOR GENTAMICIN

SYSTEM U3 FOR GENTAMICIN is an FDA 510(k)-cleared medical device (K983252) manufactured by Ab Biodisk North America, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 1998. Regulation: 8.