LUMILOC (TM) SAFETY INTRODUCER NEEDLE

LUMILOC (TM) SAFETY INTRODUCER NEEDLE is an FDA 510(k)-cleared medical device (K070449) manufactured by Specialized Health Products International, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2007. Regulation: 8.