3-DAY BIOINDICATOR RELEASE PROCESS FOR

3-DAY BIOINDICATOR RELEASE PROCESS FOR is an FDA 510(k)-cleared medical device (K833830) manufactured by Shiley, 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 April 11, 1984. Regulation: 8.