8 FRENCH DILATOR 15CM, W/LUER LOCK

8 FRENCH DILATOR 15CM, W/LUER LOCK is an FDA 510(k)-cleared medical device (K833965) manufactured by Quinton, 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 December 15, 1983. Regulation: 8.