GENTAMICIN DISK (120MCG)

GENTAMICIN DISK (120MCG) is an FDA 510(k)-cleared medical device (K961818) manufactured by Remel, L.P.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 1996. Regulation: 8.