SITERITE NEEDLE GUIDE (MODIFIED)

SITERITE NEEDLE GUIDE (MODIFIED) is an FDA 510(k)-cleared medical device (K931403) manufactured by Dymax Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 1993. Regulation: 8.